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

Model Number	24693
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device entrapment and tip detachment occurred.The patient underwent angioplasty of the target lesion located in the femoral popliteal artery.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during withdrawal, the balloon catheter was stuck on guidewire.The balloon catheter and guidewire were removed as a whole; however, the balloon catheter tip came detached on the wire.The procedure was completed with this device.No patient complications were reported.
Event or Problem Description
It was reported that device entrapment and tip detachment occurred.The patient underwent angioplasty of the target lesion located in the femoral popliteal artery.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during withdrawal, the balloon catheter was stuck on guidewire.The balloon catheter and guidewire were removed as a whole; however, the balloon catheter tip came detached on the wire.The procedure was completed with this device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter phone: (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 tip is separated.Microscopic examination revealed no damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that the tip is separated.

• 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: 17301856
• Report Number: 2124215-2023-34455
• Device Sequence Number: 17901563
• Product Code: LIT
• UDI-Device Identifier: 08714729782698
• UDI-Public: 08714729782698
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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: 07/31/2024
• Device Model Number: 24693
• Device Catalogue Number: 24693
• Device Lot Number: 0029867281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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
• Patient Sex: Unknown