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

Model Number	24703
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by mfr: returned product consisted of a sterling sl balloon catheter with an unknown.009" guidewire stuck inside the device.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a kink at the strain relief and a kink 36cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the device is kinked and there is a guidewire stuck inside the device.
Event or Problem Description
Reportable based on device analysis completed on 16nov2021.It was reported that an unknown device issue occurred.The patient presented with peripheral artery disease.A 4.0mm x 150mm x 150cm sterling sl was selected for use; however, an unknown device issue was noted.No further information is available.However, completed device analysis revealed that a guidewire was stuck inside the device.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12920831
• Report Number: 2134265-2021-14781
• Device Sequence Number: 20263531
• Product Code: DQY
• UDI-Device Identifier: 08714729782384
• UDI-Public: 08714729782384
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: 05/25/2023
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0027376621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown