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

Model Number	24703
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter facility: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the shaft detached.The stenosed target lesion was located in the superficial femoral artery.A 4.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for treatment.However, during insertion of the device the shaft fractured.A stent was implanted to secure the detached component against the vessel wall.A balloon was used to post-dilate the stent.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
E1: (b)(6).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 examination revealed that the guidewire lumen is separated 139.6cm from the hub while the balloon is separated 146.4cm from the hub.Microscopic examination revealed no damages.The tip, marker band, distal section of the balloon and distal section of the guidewire lumen are all missing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that there is a separation.
Event or Problem Description
It was reported that the shaft detached.The stenosed target lesion was located in the superficial femoral artery.A 4.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for treatment.However, during insertion of the device the shaft fractured.A stent was implanted to secure the detached component against the vessel wall.A balloon was used to post-dilate the stent.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17548676
• Report Number: 2124215-2023-42044
• Device Sequence Number: 6684275
• Product Code: DQY
• UDI-Device Identifier: 08714729782384
• UDI-Public: 08714729782384
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2024
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0029523419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male