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

Model Number	24716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in mid to distal anterior tibial artery.A 2.5x220x150 (4f) sterling balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured before reaching the rated burst pressure.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.There was blood in the inflation lumen and balloon.Microscopic examination revealed a pinhole over the proximal markerband.Microscopic examination of the balloon presented no irregularities in the balloon material or the ro marker that could have contributed to the damage.There was no other damage revealed.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in mid to distal anterior tibial artery.A 2.5x220x150 (4f) sterling balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured before reaching the rated burst pressure.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: STERLING
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9522203
• Report Number: 2134265-2019-16208
• Device Sequence Number: 16266481
• Product Code: LIT
• UDI-Device Identifier: 08714729860075
• UDI-Public: 08714729860075
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141112
• 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): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2021
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0024673045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1