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	03/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon had a hole.The 90-95% stenosed, target lesion was located in the highly calcified anterior tibial artery.A 3.0x220x150 sterling catheter was advance for dilation.However, during inflation at nominal pressure, the balloon was observed to not hold pressure.The balloon was taken out and inflated outside the body, where the physician noticed a hole.Atherectomy was performed with 2.0mm rotablator.The procedure was completed with a different device.There were no patient complications nor injuries 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 a kink 39.8cm distal from the strain relief.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole at the distal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the balloon had a hole.The 90-95% stenosed, target lesion was located in the highly calcified anterior tibial artery.A 3.0x220x150 sterling catheter was advance for dilation.However, during inflation at nominal pressure, the balloon was observed to not hold pressure.The balloon was taken out and inflated outside the body, where the physician noticed a hole.Atherectomy was performed with 2.0mm rotablator.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9903723
• Report Number: 2134265-2020-04154
• Device Sequence Number: 13616703
• Product Code: LIT
• UDI-Device Identifier: 08714729860174
• UDI-Public: 08714729860174
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/24/2020

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: 07/12/2021
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0025036246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 06/20/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1