MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24716
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the heavily calcified left superficial femoral artery.A 6.0x220x150 sterling balloon catheter was advanced for dilatation.However, during the second inflation, the balloon ruptured circumferential and a piece of the balloon remained in the patient.The procedure took an extra three hours of trying to remove the piece of the balloon by snare and also a non-bsc filter wire that sheared off in the heavily calcified lesion.The fragmented piece had to be left in the patient and a covered stent was deployed to jail it up against the wall.The filter wire also tried to be retrieved and was unsuccessful, so it was jailed up against the wall along with the balloon fragment.There were no further complications reported.
Event or Problem Description
It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the heavily calcified left superficial femoral artery.A 6.0x220x150 sterling balloon catheter was advanced for dilatation.However, during the second inflation, the balloon ruptured circumferential and a piece of the balloon remained in the patient.The procedure took an extra three hours of trying to remove the piece of the balloon by snare and also a non-bsc filter wire that sheared off in the heavily calcified lesion.The fragmented piece had to be left in the patient and a covered stent was deployed to jail it up against the wall.The filter wire also tried to be retrieved and was unsuccessful, so it was jailed up against the wall along with the balloon fragment.There were no further complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.There was a longitudinal tear 43mm long starting 100mm from the proximal end of the balloon.The balloon had a circumferential tear 143mm from the proximal end of the balloon.The inner shaft was separates at the tack weld.The distal end of the balloon and tip was missing.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9943481
• Report Number: 2134265-2020-04724
• Device Sequence Number: 13619465
• Product Code: LIT
• UDI-Device Identifier: 08714729845485
• UDI-Public: 08714729845485
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2021
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0025187239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR