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	12/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft fracture occurred.A 3.0mmx30mmx135cm (4f) sterling balloon catheter was selected for dilatation.However, the device was found fractured after unpacking before usage.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned device consisted of a sterling mr balloon catheter.The balloon was tightly folded.The tip, balloon, markerbands, proximal weld, and inner/outer shafts were microscopically and visually inspected.Inspection revealed numerous kinks in the hypotube.Inspection of the remainder of the device presented no additional damage or irregularities.The hypotube kinks are attributed to handling of the device.
Event or Problem Description
It was reported that shaft fracture occurred.A 3.0mmx30mmx135cm (4f) sterling balloon catheter was selected for dilatation.However, the device was found fractured after unpacking before usage.The procedure was completed with another of the same device.There were no patient complications 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: 8179163
• Report Number: 2134265-2018-64508
• Device Sequence Number: 19291066
• Product Code: DQY
• UDI-Device Identifier: 08714729756873
• UDI-Public: 08714729756873
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• 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): 02/21/2019

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: 08/12/2021
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0022508220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 80