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

Model Number	H74939032300410
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Adult female with history of severe peripheral arterial disease of bilateral lower extremities.Procedure: angioplasty of right and left common iliac arteries and removal of foreign body from the left common iliac artery.The balloon burst on removal- one piece of the balloon was removed with a snare, the other piece of balloon was on the wire was pulled into sheath, then into 6 french sheath and removed.No known harm to patient at this time.Incident did cause an extra procedure, overnight stay for observation.Manufacturer response for catheter, angioplasty, peripheral, transluminal, sterling (per site reporter).Will obtain, when able.

• Brand Name: STERLING
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 18309732
• Report Number: 18309732
• Device Sequence Number: 6114815
• Product Code: LIT
• UDI-Device Identifier: 08714729860136
• UDI-Public: (01)08714729860136(17)250406(10)29190717
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/01/2023
• Report Date (Section F): 12/01/2023

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 Model Number: H74939032300410
• Device Lot Number: 29190717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 52 KG
• Date Report Sent to FDA: 12/01/2023