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

Model Number	24690
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 4.5mmx20mmx135cm (4f) sterling balloon catheter was selected for use.However, during preparation when the device was pulled out of the hoop, the device came apart.The procedure was completed with another of same device.There were no patient complications reported and the patient was fine.
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 complete separation at 96.4cm distal of the strain relief.The outer shaft was stretched down starting 95.3cm distal of the strain relief and extended for 11mm.The balloon was tightly folded.The balloon protector was in place.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.A 4.5mmx20mmx135cm (4f) sterling balloon catheter was selected for use.However, during preparation when the device was pulled out of the hoop, the device came apart.The procedure was completed with another of same device.There were no patient complications reported and the patient was fine.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9938182
• Report Number: 2134265-2020-04572
• Device Sequence Number: 16304518
• Product Code: DQY
• UDI-Device Identifier: 08714729757030
• UDI-Public: 08714729757030
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141150
• 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): 06/18/2020

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: 09/11/2022
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0024417634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1