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

Model Number 24715

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2019

Event Type  malfunction  

Event 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.

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 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 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
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8863065
• MDR Text Key: 153414933
• Report Number: 2134265-2019-09302
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729845447
• UDI-Public: 08714729845447
• Combination Product (y/n): N
• PMA/PMN Number: K132430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1