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

Model Number	24702
Medical Device Problem Codes	Contamination (1120); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was contaminated.A 3.0mm x 100mm x 90cm sterling sl balloon catheter was selected for use.However, the balloon was damaged and the reel appeared dirty.The procedure was completed with different device.No patient complications were reported.
Event or Problem Description
It was reported that the device was contaminated.A 3.0mm x 100mm x 90cm sterling sl balloon catheter was selected for use.However, the balloon was damaged and the reel appeared dirty.The procedure was completed with different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual inspection revealed that the guidewire lumen within the balloon was curved with a "wavy" appearance and the balloon is deformed.There is blood present on the carrying tube.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 12144693
• Report Number: 2134265-2021-08530
• Device Sequence Number: 4170343
• Product Code: DQY
• UDI-Device Identifier: 08714729782476
• UDI-Public: 08714729782476
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 03/11/2023
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0026958087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1