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

Model Number	24715
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/23/2019
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 6.0x150x150-hybrid sterling balloon catheter was selected for dilatation.However, when the device was attempted to be pulled out of the hoop, the device was noted to be broken and kinked near the hub.The device was never used inside the patient's body and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a kink 9mm distal from the strain relief.The balloon was tightly folded.The balloon protector was still in place.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported kink.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the superficial femoral artery.A 6.0x150x150-hybrid sterling balloon catheter was selected for dilatation.However, when the device was attempted to be pulled out of the hoop, the device was noted to be broken and kinked near the hub.The device was never used inside the patient's body and the procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the device was just kinked and not broken as what was previously reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the superficial femoral artery.A 6.0x150x150-hybrid sterling balloon catheter was selected for dilatation.However, when the device was attempted to be pulled out of the hoop, the device was noted to be broken and kinked near the hub.The device was never used inside the patient's body and the procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the device was just kinked and not broken as what was previously 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: 8863065
• Report Number: 2134265-2019-09302
• Device Sequence Number: 2078794
• Product Code: LIT
• UDI-Device Identifier: 08714729845447
• UDI-Public: 08714729845447
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 09/11/2019

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: 10/19/2020
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0023678951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/06/2019; 09/03/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/15/2019; 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1