TREK™ 1012274-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648138461), received between Nov 1, 2016 and Feb 3, 2026 — classified as 2 deaths, 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Deflation Problem; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 3.0X30MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED IN THE PATIENT. HOWEVER, THE BALLOON RUPTURED AND POSSIBLY BECAME DETACHED. THIS WAS RESOLVED NON-SURGICALLY. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252022 ↗
• DeathFeb 3, 2026Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.0X30MM TREK BALLOON DILATATION CATHETER (BDC) RUPTURED AND A PIECE OF THE BALLOON BROKE OFF. THE PATIENT WENT TO THE OPERATING ROOM EMERGENTLY FOR OPEN HEART SURGERY. INITIAL SURGERY HAD NO ISSUES BUT HAD COMPLICATIONS WHILE IN THE INTENSIVE CARE UNIT AND REQUIRED MORE PROCEDURES BEFORE PASSING AWAY DURING THE HOSPITAL STAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24251849 ↗
• MalfunctionSep 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO MODERATELY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD)WITH 75% STENOSIS. A 3.00 X 30MM TREK RX BDC WAS DEVICE SOAKED PRIOR TO USE AND PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE, WITHOUT ANY ISSUES. HOWEVER, UPON INITIAL INFLATION AT 5-6 ATMOSPHERES, A BALLOON RUPTURE OCCURRED. THERE WAS NO SIGNIFICANT RESISTANCE DURING DELIVERY, NOR WERE THERE SIGNS OF SEVERE CALCIFICATION OR NODULES. THEREFORE, THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022124 ↗
• InjuryJul 1, 2025Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION THE RIGHT CORONARY ARTERY. THE 3X30MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE BALLOON FAILED TO DEFLATE, ALTHOUGH THE BALLOON WAS ATTEMPTED TO BE DEFLATED 3 OR 4 TIMES. THEREFORE, THE BDC WAS REMOVED WITH THE BALLOON INFLATED AND THE BDC BECAME STUCK WITH AN UNSPECIFIED GUIDE WIRE (GW). THE GW AND BDC HAD TO BE REMOVED TOGETHER AS A SINGLE UNIT. A DISSECTION WAS NOTED TO HAVE OCCURRED. THE PHYSICIAN WAS NOT ABLE TO GET ANOTHER GW PLACED. THE PATIENT REMAINS HOSPITALIZED AND TREATMENT FOR THE DISSECTION IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 22376056 ↗
• MalfunctionOct 29, 2024Inflation Problem; Material Separation; Inflation Problem; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) FROM THE RIGHT RADIAL APPROACH TO TREAT A COMPLETELY OCCLUDED PREVIOUSLY IMPLANTED STENT. THE 3.0X30 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON DID NOT INFLATE. IT WAS THOUGHT THAT THE BALLOON HAD RUPTURED SINCE IT WASN'T INFLATING; HOWEVER, IT WAS FOUND THAT THE SHAFT WAS SEPARATED INTO TWO PIECES AT THE GUIDE WIRE EXIT NOTCH. THE SEPARATED PIECES WERE SIMPLY WITHDRAWN. A NEW, SAME SIZE TREK BDC WAS USED IN REPLACEMENT AND THERE WERE NO ISSUES DURING USE; HOWEVER, THIS BALLOON DID NOT AFFECT THE LESION SO ANOTHER PROCEDURE WILL BE SCHEDULED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559166 ↗
• MalfunctionSep 4, 2024Inflation Problem; Off-Label Use; Stretched; Inflation Problem; Off-Label Use; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PULMONARY ARTERY. THE 3.0X30MM TREK RX BALLOON DILATATION CATHETER (BDC) COMPLETELY FAILED TO INFLATE. ANOTHER TREK RX BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THE OUTER MEMBER WAS STRETCHED AND FOLDED INWARD DISTAL TO THE MID LAP SEAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138198 ↗
• MalfunctionJul 30, 2024Break; Difficult to Advance; Material Too Soft/Flexible; Break; Difficult to Advance; Material Too Soft/Flexible

  IT WAS REPORTED THAT WHEN THE3.0X30 MM TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED ONTO THE GUIDE WIRE AND RESISTANCE WAS NOTED. THE GUIDE WIRE WAS INSIDE THE ANATOMY WHILE THE BALLOON WAS ADVANCED. THE DISTAL SHAFT OF THE TREK BDC WAS NOTED TO BE BROKEN BUT REMAINED IN ONE PIECE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS, AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19864175 ↗
• MalfunctionJul 26, 2024Off-Label Use; Material Rupture; Difficult to Advance; Off-Label Use; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE ARTERIAL PULMONARY ARTERY. THE 3.0X30MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. DURING ATTEMPTED INFLATION THE BALLOON WOULD NOT INFLATE AS IT WAS LOSING PRESSURE. THE BDC WAS REMOVED AND ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840066 ↗
• MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THERE WAS AN UNKNOWN ISSUE WITH THE 3.0X30MM RX TREK BALLOON DILATATION CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THERE WAS A SEPARATION OF THE OUTER MEMBER AND INNER MEMBER NOTED IN THE PROXIMAL SHAFT AREA. THE INNER MEMBER INSIDE THE BALLOON WAS STRETCHED. THE OUTER MEMBER DISTAL SEGMENT WAS STRETCHED AND HAD BUNCHING FOR LENGTH OF 3.5MM AT 3.5MM DISTALLY FROM THE DISTAL SEGMENT OUTER MEMBER SEPARATION END. THE OUTER MEMBER AND INNER MEMBER WERE ALSO KINKED AT 2MM PROXIMAL OF PROXIMAL BALLOON SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19631916 ↗
• InjuryOct 10, 2023Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH CALCIFICATION AND MODERATE TORTUOSITY. THE 3X30 MM TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 15 ATMOSPHERES FOR 15 SECONDS AND BECAME SEPARATED FROM THE CATHETER DURING REMOVAL AFTER 2 PRE-DILATATIONS; HOWEVER, THERE WAS NO RESISTANCE. THE BALLOON MIGRATED INTO THE AORTA. THE BALLOON WAS REMOVED FROM THE AORTA WITH A LASSO, AFTER 3 LASSOS WERE USED. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908582 ↗
• MalfunctionAug 18, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS AND 95% STENOSED. THE TREK RX BALLOON RUPTURED DURING THE SECOND INFLATION AT 14 ATMOSPHERES. RESISTANCE WAS MET WITH THE LESION DURING REMOVAL. AFTER REMOVAL OF THE TREK, A NEW UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17578198 ↗
• MalfunctionApr 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION AND BEFORE USE IN THE PATIENT, WHEN THE TREK RX WAS REMOVED FROM THE PACKAGING IT BROKE AT THE SHAFT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14214424 ↗
• DeathFeb 22, 2022Unintended System Motion; Difficult to Remove; Material Separation; Failure to Deflate; Unintended System Motion; Difficult to Remove; Material Separation; Failure to Deflate

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN IN-STENT RESTENOSIS IN THE CIRCUMFLEX CORONARY ARTERY. THE IN-STENT RESTENOSIS WAS TREATED WITH TWO BALLOON INFLATIONS. WHILE IN THE CIRCUMFLEX ARTERY, A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION WAS NOTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH INTRAVASCULAR ULTRASOUND (IVUS). A TREK RX 3 X 30MM BALLOON DELIVERY CATHETER (BDC) WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY AND WAS THEN INSERTED AND WAS INFLATED. THEN IT WAS NOTED THERE WAS NO FLOW IN THE CIRCUMFLEX ARTERY AND THE PATIENT EXPERIENCED AN INCREASED HEART RATE AND A DROP IN BLOOD PRESSURE. THE PHYSICIAN DECIDED TO REMOVE THE BDC; HOWEVER, IT WAS NOTED THE BALLOON WOULD NOT DEFLATE AND RESISTANCE WAS FELT. THE BALLOON SHAFT WAS REMOVED AND IT WAS OBSERVED THE BALLOON HAD COMPLETELY DISLODGED FROM THE SHAFT AND WAS OBSERVED IN THE LEFT MAIN CORONARY ARTERY. SHORTLY AFTER THIS OCCURRED, THE PATIENT CODED AND THEN PASSED AWAY. IT WAS SUSPECTED THIS WAS CAUSED BY THE DISLODGED BDC. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia; Cardiac Arrest; Cardiogenic Shock; Foreign Body In Patient; Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Tachycardia

  MAUDE report 13581700 ↗
• InjuryFeb 21, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  USER FACILITY MEDWATCH REPORT (MW5106318) RECEIVED STATING: WHEN THE DEVICE WAS BEING REMOVED FROM THE PATIENT, IT BECAME STUCK TO AN AREA OF CALCIUM IN THE PATIENT'S VESSEL. ULTIMATELY DISLODGING THE BALLOON SHAFT BECOMING RETAINED. ADDITIONALLY, IT WAS REPORTED THAT THE 3.00 X 30MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE TO THE MODERATELY CALCIFIED LESION IN THE PROFUNDA ARTERY. THE BALLOON WAS INFLATED TWICE AND DEFLATED WITHOUT ISSUE. DURING REMOVAL, RESISTANCE WAS NOTED DUE TO CALCIFICATION IN THE VESSEL AND THE DISTAL SHAFT, INCLUDING THE BALLOON SEPARATED. SNARING WAS PERFORMED IN AN ATTEMPT TO REMOVE THE SEPARATED PORTION OF THE DEVICE, BUT IT WAS NOT SUCCESSFUL, SO A BARE METAL STENT WAS ADVANCED AND IMPLANTED TO SECURE THE SEPARATED PORTION. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13573539 ↗
• InjuryOct 12, 2021Deflation Problem; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE DEVICE COMPLETELY FAILED TO DEFLATE; THEREFORE, THE BALLOON WAS INTENTIONALLY RUPTURED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615622 ↗
• MalfunctionFeb 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, NON-TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X30MM TREK BALLOON RUPTURED AT 10ATM ON THE FIRST INFLATION. THERE WAS NO RESISTANCE NOTED. THE CATHETER WAS REMOVED WITHOUT ISSUE AND REPLACED WITH A NEW TREK BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11276159 ↗
• MalfunctionMar 13, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.0X30MM TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BDC WAS INFLATED TO 12-14 ATMOSPHERES; HOWEVER, THE BALLOON FAILED TO FULLY DEFLATE. AFTER ABOUT 45 SECONDS, THE BALLOON PARTIALLY DEFLATED AND WAS REMOVED. THE PATIENT HAD ANGINA AND IT WAS MANAGED SUBSEQUENTLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED TREK BDC. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9831386 ↗
• MalfunctionDec 3, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE BALLOON WAS INFLATED TWICE TO 14 ATMOSPHERES AND THE BALLOON DEFLATED SUCCESSFULLY. THE RESISTANCE WAS WITH A 6F GUIDE CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9406716 ↗
• MalfunctionSep 18, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH NO TORTUOSITY AND NO CALCIFICATION. THE 3.00 X 30 MM TREK RX BALLOON WAS INFLATED ONCE TO 14 ATMOSPHERES. THE BALLOON WAS ATTEMPTED TO BE DEFLATED BY HOLDING NEGATIVE FOR 10 SECONDS; HOWEVER, THE BALLOON FAILED TO COMPLETELY DEFLATE. AS THE ARTERY DIAMETER WAS GREATER THAN THE PARTIALLY DEFLATED BALLOON DIAMETER, THE BALLOON DILATATION CATHETER WAS SIMPLY REMOVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084250 ↗
• InjuryAug 19, 2019Off-Label Use; Difficult to Remove; Material Separation; Failure to Advance; Off-Label Use; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THIS WAS A PROCEDURE PERFORMED TO TREAT A HEAVILY CALCIFIED TARGET LESION IN AN UNSPECIFIED BELOW-THE-KNEE, LOWER EXTREMITY ARTERY. DURING ADVANCEMENT OF THE TREK DILATATION CATHETER, THE DEVICE WAS UNABLE TO CROSS TO THE TARGET LESION AND BECAME TRAPPED IN THE VESSEL CALCIFICATION. AN ATTEMPT WAS MADE TO REMOVE THE DEVICE; HOWEVER, RESISTANCE WAS NOTED AND THE DISTAL BALLOON PORTION OF THE DILATATION CATHETER SEPARATED, REMAINING IN THE PATIENT ANATOMY. A SNARE DEVICE WAS ADVANCED AND THE SEPARATED SEGMENT WAS ABLE TO BE REMOVED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INTERVENTION WAS PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8908257 ↗
• MalfunctionMar 7, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A XIENCE SIERRA STENT WAS IMPLANTED IN THE LAD. BALLOON ANGIOPLASTY WAS PERFORMED AT AN UNSPECIFIED DIAGONAL ARTERY. KISSING BALLOON TECHNIQUE (KBT) WAS PERFORMED USING A 3.0X30MM TREK BALLOON DILATATION CATHETER IN THE LAD AND A 3.X18MM XIENCE SIERRA STENT-BALLOON IN THE DIAGONAL BRANCH, WHERE THE STENT HAD BEEN IMPLANTED. KBT WAS PERFORMED SUCCESSFULLY AND BOTH BALLOONS DEFLATED WITHOUT ISSUE. WHILE THE TREK BALLOON WAS BEING REMOVED, RESISTANCE WAS FELT BUT CANNOT BE DETERMINED WITH WHAT. UPON REMOVAL, IT WAS NOTED THAT THE TREK HYPOTUBE SEPARATED AND REMAINED IN THE GUIDING CATHETER. THE SEPARATED PORTION WAS REMOVED WITH THE GUIDING CATHETER AS A SINGLE UNIT. A NON-ABBOTT GUIDING CATHETER WAS INSERTED AND ENGAGED IN LEFT CORONARY ARTERY. FINAL ANGIOGRAPHY WAS THEN PERFORMED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8400286 ↗
• MalfunctionApr 18, 2017Detachment Of Device Component

  IT WAS REPORTED THAT A 3.0 X 30 MM TREK BALLOON DILATATION CATHETER (BDC) WAS OBSERVED TO HAVE A PROXIMAL SHAFT SEPARATION PRIOR TO USE. THE SHAFT WAS SEPARATED INTO TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT WITH THE DEVICE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6502402 ↗
• MalfunctionNov 1, 2016Material Rupture

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE, THE 3.0 X 30 MM TREK DILATATION CATHETER WAS ADVANCED INTO THE PATIENT ANATOMY. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, IT WAS NOTED THAT THE BALLOON DID NOT INFLATE AT ALL AND IT WAS THOUGHT THAT THERE WAS A HOLE IN THE BALLOON; HOWEVER, NO CONTRAST WAS SEEN COMING FROM THE DEVICE. THE TREK DILATATION CATHETER WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT DIFFICULTY AND A SECOND SAME DEVICE WAS USED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6071484 ↗