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	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age at the time of event: 70s.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified superficial femoral artery.A 4.0x220x150 sterling balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.The device was completely removed intact and the procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Patient age at the time of event: 70s.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified superficial femoral artery.A 4.0x220x150 sterling balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.The device was completely removed intact and the procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that there was 50% stenosis during post atherectomy.The balloon ruptured at initial inflation.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10412522
• Report Number: 2134265-2020-11189
• Device Sequence Number: 14055870
• Product Code: LIT
• UDI-Device Identifier: 08714729860310
• UDI-Public: 08714729860310
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/21/2020

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: 08/16/2021
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0025222363
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1