Sterling® SL H74939148301510Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08714729782315), received between Nov 14, 2018 and Jul 9, 2026 — classified as 4 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (23 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND DETACHMENT OCCURRED AND DEVICE FRAGMENT REMAINED INSIDE THE PATIENT AND WAS REMOVED WITH A RETRIEVAL DEVICE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 3 ATMOSPHERES FOR 2 MINUTES, THE BALLOON RUPTURED AND FRACTURED. THE DEVICE FRAGMENTS REMAINED INSIDE THE BODY; THEREFORE, A RETRIEVAL DEVICE (SNARE) WAS USED TO REMOVE THE FRAGMENTS. THIS INCIDENT DELAYED THE SURGICAL PROCEDURE AND INCREASED THE SURGICAL DURATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25771522 ↗
• MalfunctionMar 31, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90-100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED TIBIAL AND POPLITEAL ARTERY. A 4.0MM X 100MM X 135CM (4F) STERLING AND 3.0MM X 150MM X 150CM STERLING SL BALLOON WERE SELECTED FOR USE. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741145 ↗
• MalfunctionNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, UPON DILATING THE BALLOON IT WAS NOTED THAT IT COULD NOT INFLATED AND WAS RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23518724 ↗
• MalfunctionOct 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. A 60-YEAR-OLD MALE PATIENT UNDERWENT A BALLOON ANGIOPLASTY FOR RIGHT LOWER EXTREMITY ARTERIAL OCCLUSION. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE INITIAL BALLOON CATHETER WAS DAMAGED DUE TO VESSEL CALCIFICATION AND FAILED TO INFLATE PROPERLY. THE BALLOON WAS RUPTURES ONCE AT 10 ATMOSPHERE PER SECOND. AFTER INFLATION, THE CONTRAST AGENT LEAKED OUT AND THE BALLOON RETRACTED RAPIDLY. THE BALLOON WAS REMOVED ALONG THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373714 ↗
• MalfunctionOct 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH A LEFT LOWER EXTREMITY ARTERY OCCLUSION. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED ALONG WITH THE GUIDEWIRE FOR DILATION. DURING INFLATION, THE BALLOON BURST AND COULD NOT BE DILATED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334750 ↗
• MalfunctionJul 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE 80% STENOSIS TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664030 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Inflation Problem; Leak/Splash; Material Rupture; Fluid/Blood Leak; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS CRACKED, RESULTING IN LIQUID LEAKAGE AND INFLATION FAILURE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCE FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS CRACKED, RESULTING IN LIQUID LEAKAGE AND INFLATION FAILURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543616 ↗
• MalfunctionJun 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE VESSEL BELOW THE KNEE. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST AS SOON AS THE CONTRAST WAS INJECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210019 ↗
• InjuryFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT FRAGMENT OF THE BALLOON DETACHED. A 3.0MM X 150MM X 150CM STERLING BALLOON CATHETER WAS ADVANCE FOR USED. DURING THE ANGIOPLASTY OF THE FEMORAL BYPASS GRAFT, A FRAGMENT OF THE BALLOON DETACHED FROM THE DEVICE AND REMAINED LODGED WITHIN THE PATIENT'S ARTERY. THE PHYSICIAN DEPLOYED A STENT TO SECURE THE FRAGMENT IN PLACE, AND IT WAS RETAINED WITHIN THE PATIENT'S VASCULATURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21411257 ↗
• MalfunctionJan 24, 2025

  PATIENT ARRIVED FOR ANGIOGRAM PROCEDURE WITH DOCTOR. WHILE DOING AN ANGIOPLASTY TO THE FEMORAL BYPASS GRAFT, A PIECE OF THE BALLOON BROKE OFF THE DEVICE AND REMAINED INSIDE THE PATIENTS ARTERY. DOCTOR USED A STENT TO CAPTURE IT IN PLACE, BUT THE PIECE DID REMAIN INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21228528 ↗
• MalfunctionJan 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, AFTER MULTIPLE INFLATIONS, THE BALLOON RUPTURED AT 14 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED INTACT WITH THE SHAFT AND THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. THERE WERE NO COMPLICATIONS, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107950 ↗
• MalfunctionJan 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS BEING TREATED FOR CHRONIC LIMB-THREATENING ISCHEMIA IN A LOWER LIMB. A 3.0MM X 150MM X 150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 14 ATMOSPHERES, AFTER A FEW INFLATIONS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106973 ↗
• MalfunctionOct 14, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL VEIN. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON RATED BURST PRESSURE. THE DEVICE WAS DOUBLE WIRED AND REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440885 ↗
• MalfunctionJul 12, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS BURST AND CONTRAST MEDIUM COMES OUT OF THE BALLOON. THE BALLOON DID NOT INFLATE AND THERE WAS A LEAK NOTED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735766 ↗
• MalfunctionFeb 27, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07FEB2024. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS USED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE CONTRAST AGENT WAS LEAKING, AND THE BALLOON WAS ABLE TO INFLATE BUT UNABLE TO DILATE THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PINHOLE 9MM FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18792712 ↗
• MalfunctionNov 13, 2023Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LOWER PATELLAR ARTERY OF LOWER LIMB. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION AND WAS INFLATED TO 6 ATMOSPHERES. THE DEVICE WAS REMOVED THROUGH SHEATH. AFTER REMOVAL, IT WAS FOUND THAT THE BALLOON HAD BURST, AND THE CATHETER WAS TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18119284 ↗
• InjuryOct 6, 2023Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS A SHAFT BREAK AND INABILITY TO REMOVE A FRAGMENT OF THE DEVICE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 3.0MM X 150MM X 150CM FG STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON WAS FRACTURED IN THE DISTAL PORTION OF THE BALLOON THAT CONTAINED THAT DISTAL RO MARKER ABOUT 5-10 MM FROM THE TIP. THE MAJORITY OF THE CATHETER WAS REMOVED BUT THE DISTAL TIP WAS STUCK IN THE MID SFA. PHYSICIAN ATTEMPTED TO SNARE THE DEVICE OUT NUMEROUS TIMES BUT WAS UNABLE TO RETRIEVE IT. THE PHYSICIAN THEN PROCEEDED WITH ANGIOPLASTY, FOLLOWED BY PLACING A STENT, AND YET THE PIECE WAS NOT MOVING OR OBSTRUCTING FLOW. AFTER SEEING THE POST ANGIOGRAM RESULT, PATIENT HAD SIGNIFICANT IMPROVEMENT IN FLOW AND THE PHYSICIAN LEFT THE FRACTURED PIECE OF THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17889746 ↗
• MalfunctionJun 22, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023: IT WAS REPORTED, THAT BALLOON LEAK WAS ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY AND INFRAPOPLITEAL. A 3.0MM X 150MM X 150CM FG STERLING BALLOON CATHETER WAS PREPARED BY FLUSHING. HOWEVER, DURING PREPARATION, IT WAS OBSERVED THAT THE BALLOON WAS LEAKING GAS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182056 ↗
• MalfunctionMar 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERIPHERAL ANGIOPLASTY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED IN ITS MIDDLE PART. THE DEVICE WAS PULLED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539860 ↗
• MalfunctionFeb 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE PROXIMAL OF THE BALLOON WAS SEPARATED FROM THE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405186 ↗
• MalfunctionJan 26, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE STENOSED TARGET LESION WAS LOCATED IN THE INFRAPOPLITEAL ARTERY OF THE LOWER LIMB. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN WITHDRAWING THE BALLOON, THE RETRIEVAL WAS DIFFICULT AND THE GUIDEWIRE COULD NOT ALSO BE WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 2.5X150 BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247065 ↗
• MalfunctionSep 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED. THE TARGET LESION WAS LOCATED IN ANTERIOR TIBIAL ARTERY. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN INFLATED AT HIGH PRESSURE, THE BALLOON WAS BURST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477999 ↗
• MalfunctionAug 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 2.5MM STENOSED TARGET LESION WAS LOCATED IN THE NON- TORTUOUS AND MILDLY CALCIFIED FEMORAL VEIN. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON TWICE AT 8 ATMOSPHERES (ATM) BUT FAILED, THE DEVICE WAS THEN REMOVED AND RE-ENTERED INTO THE LESION SITE. THE BALLOON WAS PARTIALLY INFLATED AT 8 ATM. SO, THE PHYSICIAN INCREASED THE ATMOSPHERES TO 10 ATM, THE BALLOON WAS FULLY DEPLOYED AFTER 5-10 MINUTES. THE DEVICE WAS REMOVED AND WAS INTRODUCED INTO ANOTHER LESION TO INFLATE AGAIN. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15291024 ↗
• MalfunctionJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-JUN-2022. IT WAS REPORTED THAT NO KNOWN DEVICE PROBLEM ENCOUNTERED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 100% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND CALCIFIED PERONEAL ARTERY. A 3.0 X 220 X 150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 3 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT'S BODY. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS THEN USED FOR DILATION. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14777066 ↗
• InjuryApr 27, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL VASCULAR DISEASE (PVD). THE 99% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND SEVERELY CALCIFIED BEND OF THE ANTERIOR TIBIAL ARTERY. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION AND INFLATION WAS PERFORMED. HOWEVER, REMOVAL DIFFICULTIES WERE ENCOUNTERED AND THE SHAFT OF THE BALLOON SHEARED OFF IN TWO PIECES OVER THE WIRE. A SNARE WAS ADVANCED THEN AND THE SHEARED PORTION WAS RETRIEVED WITH NO COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14229393 ↗