MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24703
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a hole in the balloon.A 4mm x 120mm x 150cm sterling sl balloon catheter was selected for use in a peripheral angioplasty procedure.While inserting the device over the wire, a hole in the balloon was observed.The device was not introduced into the patient's artery.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a hole in the guidewire lumen 20mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there was a hole in the guidewire lumen.
Event or Problem Description
It was reported that there was a hole in the balloon.A 4mm x 120mm x 150cm sterling sl balloon catheter was selected for use in a peripheral angioplasty procedure.While inserting the device over the wire, a hole in the balloon was observed.The device was not introduced into the patient's artery.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11967845
• Report Number: 2134265-2021-07442
• Device Sequence Number: 3173249
• Product Code: DQY
• UDI-Device Identifier: 08714729782377
• UDI-Public: 08714729782377
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 03/08/2023
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0026928368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1