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

Model Number	24700
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred and removal difficulties were encountered.The target lesion was located in the subclavian vein.A 10.0mm x 40mm x 80cm sterling balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured horizontally.Resistance was encountered upon removing the device, so the device was removed together with the sheath.There were no patient complications reported and the patient's status was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter and part of an introducer sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the device is stuck inside an introducer sheath.The balloon is torn circumrenal and pulled over the tip.There are multiple kinks along the guidewire lumen at the separation area.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred and removal difficulties were encountered.The target lesion was located in the subclavian vein.A 10.0mmx40mmx80cm sterling balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured horizontally.Resistance was encountered upon removing the device, so the device was removed together with the sheath.There were no patient complications reported and the patient's status was good.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10244300
• Report Number: 2134265-2020-08999
• Device Sequence Number: 18966752
• Product Code: DQY
• UDI-Device Identifier: 08714729123453
• UDI-Public: 08714729123453
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053116
• 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): 08/19/2020

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: 02/06/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023308242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1