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

Model Number	24700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the superficial femoral artery.A 6.0mmx40mmx135cm sterling balloon catheter was selected for use.However, it was noticed that the balloon was already broken in the package inside the plastic wrap.The procedure was completed with another of the same device.No patient complications nor injuries reported and the patient's status was good.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the superficial femoral artery.A 6.0mmx40mmx135cm sterling balloon catheter was selected for use.However, it was noticed that the balloon was already broken in the package inside the plastic wrap.The procedure was completed with another of the same device.No patient complications nor injuries reported and the patient's status was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.Device was returned in carton in carrier tube.The balloon was loosely folded and "wavy" for the length of the balloon.Inspection of the balloon revealed that it was unfolded/deformed and the inner shaft within the balloon was curved with a "wavy" appearance.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: 10295388
• Report Number: 2134265-2020-09485
• Device Sequence Number: 16752355
• Product Code: DQY
• UDI-Device Identifier: 08714729122784
• UDI-Public: 08714729122784
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: 04/24/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025469436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1