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

Model Number	24690
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Given event date: (b)(6) 2018.Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the inflation lumen and core wire.The balloon is separated 138.2cm from the hub.Microscopic examination revealed that the guidewire lumen is separated 134cm from the hub.The distal section of the separations are missing.The missing sections are the distal guidewire lumen, distal balloon, marker bands, and tip.There is blood present in the hub, inflation lumen, guidewire lumen, and balloon.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 23-jan-2019.It was reported that balloon damage occurred.A 6.0mmx30mmx135cm sterling balloon catheter was advanced for dilation; however, failure of the balloon was noted.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed balloon separation.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8336952
• Report Number: 2134265-2019-01117
• Device Sequence Number: 16525640
• Product Code: DQY
• UDI-Device Identifier: 08714729757276
• UDI-Public: 08714729757276
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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: 09/04/2021
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0022609200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1