NC TREK 1012453-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08717648152085), received between Apr 3, 2018 and Dec 4, 2024 — classified as 1 death, 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (9 reports).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jan 29, 2020Terminated

   Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

   Z-1131-2020 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2024Material Separation; Component Missing; Material Separation; Component Missing

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS STATED THAT THE DEVICE WAS FLUSHED WITH SALINE WHICH MAY HAVE CONTAINED BLOOD BUT THE DEVICE WAS NOT ADVANCED ONTO A GUIDE WIRE OR GUIDING CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847709 ↗
• MalfunctionJul 11, 2024Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED IT WAS NOTED THAT THE BALLOON DILATATION CATHETER (BDC) WAS REMOVED WITH THE ENTIRE SYSTEM. CONTRAST RATIO WAS 1 TO 2. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726024 ↗
• MalfunctionNov 16, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18156550 ↗
• MalfunctionSep 19, 2023Material Separation; Material Separation

  A PHOTO WAS PROVIDED OF AN UNSPECIFIED NC TREK THAT APPEARS TO BE SEPARATED INTO SEPARATE PIECES. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17776196 ↗
• MalfunctionMar 21, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DURING A MODERATELY CALCIFIED OBTUSE MARGINAL AND CIRCUMFLEX ARTERY INTERVENTION, THE 4.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESIONS WITHOUT ISSUE AND PRE-DILATATION WAS SUCCESSFULLY COMPLETED. AFTER REMOVAL OF THE BDC, UNSPECIFIED STENTS WERE IMPLANTED. THE BDC WAS INSERTED INTO THE ANATOMY AGAIN AND ADVANCED TO PERFORM POST-DILATATION IN THE CX ARTERY. THE BALLOON WAS INFLATED WITHOUT ISSUE, BUT COULD NOT BE DEFLATED. TROUBLE SHOOTING WAS PERFORMED, BUT THE BALLOON FAILED TO DEFLATE AND THE PATIENT DEVELOPED CHEST PAIN. THE BDC, GUIDEWIRE AND SHEATH WERE REMOVED AS A SINGLE UNIT AND THE CHEST PAIN RESOLVED. THE PROCEDURE WAS DEEMED SUCCESSFUL AND WAS DONE. THERE WAS NO ADVERSE PATIENT SEQUELA. A REPLACEMENT DEVICE WAS NOT NEEDED AS POST-DILATATION WAS COMPLETE AT THIS POINT AND THE TARGET LESIONS WERE ALREADY TREATED. THE PT IS STABLE. ALTHOUGH THERE WAS A 10-15 MIN DELAY, IT WAS NOT CLINICALLY SIGNIFICANT. THE PT WAS DISCHARGED THE NEXT DAY AS PLANNED.

  Patient problems: Angina

  MAUDE report 16587200 ↗
• MalfunctionNov 4, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CORONARY ARTERY (LCA) WITH 85% STENOSIS, MILD CALCIFICATION AND MILD TORTUOSITY. THE 4.0X20MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS INFLATED THREE TIMES AT 12, 18 AND 20 ATMOSPHERES (ATMS), RESPECTIVELY, AND WAS LOSING PRESSURE. THE BALLOON COULD NOT BE INFLATED DURING POST IMPLANTATION OF A 3.5X28MM XIENCE SIERRA STENT. THE BDC WAS NOT SOAKED AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE DURING ADVANCEMENT. A 4.0X15MM NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. 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 15734758 ↗
• MalfunctionOct 11, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH DEFLATION WITH THE 4.0X20 MM NC TREK BALLOON DILATATION CATHETER. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576300 ↗
• MalfunctionJul 15, 2022Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO USE, WHEN THE STAFF SELECTED THE 4.0X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) BOX, THE BOX WAS SLIGHTLY TORN AND A USED DEVICE WAS INSIDE. THE BALLOON WAS BLOODY AND THE POUCH WAS OPENED. THE DEVICE WAS NOT USED (IN THIS PROCEDURE) AND THERE WAS NO PATIENT INVOLVEMENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15030039 ↗
• InjuryJan 20, 2022Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT DURING DEVICE PREPARATION RESISTANCE WAS NOTED WHEN REMOVING THE STYLET OR PROTECTIVE SHEATH. DURING THE CORONARY ARTERY INTERVENTION, AFTER MULTIPLE INFLATIONS TO NOMINAL, THE NC TREK BALLOON FAILED TO DEFLATE. TROUBLESHOOTING WAS ATTEMPTED TO DEFLATE THE BALLOON INCLUDING THE USE OF A SYRINGE, BUT THE BALLOON FAILED TO DEFLATE. THE DEVICE WAS PULLED TO THE GUIDE CATHETER AND THE SHEATH CUT TO DEFLATE THE BALLOON, THEN THE BALLOON AND GUIDE CATHETER WERE REMOVED AS A UNIT. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13309840 ↗
• MalfunctionAug 27, 2021Inflation Problem; Stretched; Inflation Problem; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 4.0X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ABLE TO HOLD PRESSURE BUT COULD ONLY PARTIALLY INFLATE INSIDE THE PREVIOUSLY IMPLANTED STENT. THERE WAS NO DIFFICULTY IN REMOVING THE STYLET OR PROTECTIVE SHEATH. ANOTHER NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED A STRETCHED INNER/OUTER MEMBER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378821 ↗
• MalfunctionAug 6, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE 4.00X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED OUTSIDE THE ANATOMY AND THE CONTRAST MIX RATIO WAS 50/50. THE BDC WAS INFLATED ONCE TO DILATE THE ARTERY. AFTER INFLATION, THE BALLOON FAILED TO DEFLATE AND COULD NOT BE RETRIEVED INTO THE GUIDING CATHETER AND COULD NOT ADVANCE FURTHER IN THE RADIAL ARTERY. A SURGEON WAS CALLED AND A CUT DOWN WAS PERFORMED TO RETRIEVE THE BALLOON FROM THE RADIAL ARTERY. A SECOND 4.00X20MM NC TREK BDC WAS ALSO PREPPED OUTSIDE THE ANATOMY AND THE CONTRAST MIX RATIO WAS 50/50. THE BDC WAS ADVANCED THROUGH A 6F GUIDING CATHETER THROUGH ACCESS ON THE OTHER SIDE VIA THE LEFT RADIAL ARTERY. THE BDC WAS INFLATED FIVE TIMES AT 20 ATMOSPHERES. ALTHOUGH NEGATIVE PRESSURE WAS HELD FOR 15 SECONDS, THE BDC ONLY PARTIALLY DEFLATED. THE BDC WAS ABLE TO BE RETRACTED INTO THE GUIDING CATHETER AND BOTH WERE REMOVED FROM THE PATIENT ANATOMY AS A SINGLE UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE PATIENT IN GOOD CONDITION. THERE WERE NO ADVERSE PATIENT SEQUELA AND A PROCEDURAL DELAY OF THREE HOURS OCCURRED DUE TO THE SURGICAL INTERVENTION FOR THE FIRST TR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10373935 ↗
• InjuryAug 6, 2020Deflation Problem; Entrapment of Device; Deflation Problem; Entrapment of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE 4.00X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED OUTSIDE THE ANATOMY AND THE CONTRAST MIX RATIO WAS 50/50. THE BDC WAS INFLATED ONCE TO DILATE THE ARTERY. AFTER INFLATION, THE BALLOON FAILED TO DEFLATE AND COULD NOT BE RETRIEVED INTO THE GUIDING CATHETER AND COULD NOT ADVANCE FURTHER IN THE RADIAL ARTERY. A SURGEON WAS CALLED AND A CUT DOWN WAS PERFORMED TO RETRIEVE THE BALLOON FROM THE RADIAL ARTERY. A SECOND 4.00X20MM NC TREK BDC WAS ALSO PREPPED OUTSIDE THE ANATOMY AND THE CONTRAST MIX RATIO WAS 50/50. THE BDC WAS ADVANCED THROUGH A 6F GUIDING CATHETER THROUGH ACCESS ON THE OTHER SIDE VIA THE LEFT RADIAL ARTERY. THE BDC WAS INFLATED FIVE TIMES AT 20 ATMOSPHERES. ALTHOUGH NEGATIVE PRESSURE WAS HELD FOR 15 SECONDS, THE BDC ONLY PARTIALLY DEFLATED. THE BDC WAS ABLE TO BE RETRACTED INTO THE GUIDING CATHETER AND BOTH WERE REMOVED FROM THE PATIENT ANATOMY AS A SINGLE UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE PATIENT IN GOOD CONDITION. THERE WERE NO ADVERSE PATIENT SEQUELA AND A PROCEDURAL DELAY OF THREE HOURS OCCURRED DUE TO THE SURGICAL INTERVENTION FOR THE FIRST TR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10373806 ↗
• MalfunctionMay 21, 2020Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 4X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON WAS INFLATED ONCE TO 24 ATMOSPHERES. HOWEVER, THE BALLOON ONLY PARTIALLY DEFLATED WITHIN THE UNSPECIFIED STENT. THE PARTIALLY DEFLATED BALLOON WAS RETRACTED INTO THE GUIDE CATHETER WITH RESISTANCE AND FORCE APPLIED. THE SHAFT OF THE BDC SEPARATED, SO THE WHOLE SYSTEM WAS REMOVED. A NON-ABBOTT BALLOON WAS USED 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: No Consequences Or Impact To Patient

  MAUDE report 10079390 ↗
• DeathFeb 19, 2020Deflation Problem; Material Rupture; Deflation Problem; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION. A PERCUTANEOUS CORONARY INTERVENTION WAS INITIATED ON THE LEFT ANTERIOR DESCENDING (LAD), MODERATELY CALCIFIED LESION. AN NC TREK (1012453-20, 90923G1) DILATATION CATHETER ADVANCED TO THE LESION SITE AND INFLATED WITHOUT REPORTED ISSUES. DEFLATION WAS ATTEMPTED; HOWEVER, THE BALLOON WAS UNABLE TO DEFLATE. AS TROUBLESHOOTING, THE BALLOON WAS RE-INFLATED. THE BALLOON HAD THEN RUPTURED AND THE LAD PERFORATED. A COVERED STENT WAS IMPLANTED AS TREATMENT. THE DIAGONAL CORONARY ARTERY THEN ¿SHUT DOWN¿. PERICARDIOCENTESIS WAS PERFORMED. ON (B)(6) 2020, THE PATIENT HAD EXPIRED WHILE IN CRITICAL CARE. NO ADDITIONAL INFORMATION AS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Death; Occlusion; Perforation

  MAUDE report 9727825 ↗
• MalfunctionNov 27, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-CALCIFIED LESION IN THE MILDLY TORTUOUS RENAL ARTERY. THE 4.0X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE WITHOUT ISSUE BUT COMPLETELY FAILED TO DEFLATE. NEGATIVE PRESSURE WAS ATTEMPTED FOR SEVERAL MINUTES TO DEFLATE THE BDC BUT WAS UNSUCCESSFUL. RESISTANCE WAS NOTED WITH THE GUIDE CATHETER AND THE BDC WAS REMOVED FULLY INFLATED WITH THE GUIDE CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9385595 ↗
• MalfunctionJun 14, 2019Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-CALCIFIED LESION IN THE MILDLY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). THE 4.00 X 20 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND RUPTURED AT 5 ATMOSPHERES DURING THE FIRST INFLATION. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND A LINEAR SPLIT WAS NOTED ONCE OUTSIDE THE ANATOMY. A 4.5 X 20 MM NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8700637 ↗
• MalfunctionSep 19, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED AND POST-DILATATION WAS PERFORMED WITH A 4.0 X 20 MM NC TREK BALLOON DILATATION CATHETER (BDC). THE DEVICE DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT, AND THE BALLOON WAS INFLATED AT 14 ATMOSPHERES (ATMS) AND THEN AT 12 ATMS. HOWEVER, THE BALLOON WAS UNABLE TO BE DEFLATED; THEREFORE, THE DEVICE WAS GENTLY PULLED OUT OF THE ANATOMY WITH THE BALLOON FULLY INFLATED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONALLY, A VOLUNTARY MEDWATCH REPORT WAS RECEIVED WHICH STATES: POST STENT PTCA LAD, BALLOON WOULD NOT DEFLATE IN ARTERY. HAD TO BE PULLED OUT INFLATED. NO HARM BUT POTENTIAL TO DELAY IN PROCEDURE. DEVICE WAS PREPPED PRIOR TO USE. NO RESISTANCE DURING ADVANCEMENT. DEVICE WAS INFLATED TWICE IN THE PROCEDURE, FIRST TO 14 THEN 12. BALLOON WOULD NOT DEFLATE UNTIL REMOVED FROM THE ARTERY. MILD CALCIUM AND TORTUOSITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889382 ↗
• MalfunctionJun 21, 2018Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH NO TORTUOSITY AND NO CALCIFICATION. A 4.0 X 20 MM NC TREK BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. THE BALLOON CATHETER BECAME STUCK WITH THE GUIDING CATHETER DURING REMOVAL, AND THEREFORE BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. REPORTEDLY, THE TIP OF THE GUIDING CATHETER HAD A DEFORMED TIP AND BECAME CAUGHT ON THE BALLOON DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN UNSPECIFIED BALANCE MIDDLE WEIGHT GUIDE WIRE AND A 4.0 X 15 MM NC TREK BALLOON CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7626429 ↗
• MalfunctionJun 5, 2018Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY. THE 4.0 X 20 MM NC TREK DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION FOR POST-DILATATION OF AN UNSPECIFIED STENT. THE DILATATION CATHETER BALLOON WAS INFLATED AND NO ISSUES WERE NOTED; HOWEVER, DURING DEFLATION, THE BALLOON WOULD NOT FULLY DEFLATE. THE BALLOON WAS INFLATED AND DEFLATED A FEW TIMES AND THE BALLOON FINALLY DEFLATED ENOUGH TO BE REMOVED FROM THE PATIENT ANATOMY. THERE WAS NO DIFFICULTY NOTED DURING REMOVAL FROM THE PATIENT ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7571769 ↗
• MalfunctionApr 3, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE 4.0X20 MM NC TREK WAS BEING ADVANCED THROUGH THE GUIDE CATHETER TO TREAT THE RIGHT CORONARY ARTERY WHEN THE PROXIMAL SHAFT (HYPOTUBE) NEAR THE HUB SEPARATED IN TWO PIECES OUTSIDE THE ANATOMY. NO RESISTANCE WAS FELT DURING ADVANCEMENT. THE NC TREK WAS EASILY WITHDRAWN. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7392604 ↗