MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
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
Medwatch report number: 3600840000-2023-8108.It was reported that the balloon burst requiring additional intervention.The target lesion was located in the right and left common iliac arteries.A 3.0x40x150 (4f) sterling was selected for an angioplasty procedure and for removal of a foreign body from the left common iliac artery.The balloon burst upon removal from the patient.A snare was used to remove one piece of the balloon.The other piece of the balloon was on the guidewire and pulled into the 6f sheath, then removed from the patient.An extra procedure was performed, and the patient stayed in the hospital overnight for observation.There were no patient complications reported.
Event or Problem Description
Medwatch report number: 3600840000-2023-8108.It was reported that the balloon burst requiring additional intervention.The target lesion was located in the right and left common iliac arteries.A 3.0x40x150 (4f) sterling was selected for an angioplasty procedure and for removal of a foreign body from the left common iliac artery.The balloon burst upon removal from the patient.A snare was used to remove one piece of the balloon.The other piece of the balloon was on the guidewire and pulled into the 6f sheath, then removed from the patient.An extra procedure was performed, and the patient stayed in the hospital overnight for observation.There were no patient complications reported.It was further reported that the removal of the 2 portions of balloon were removed during the same procedure.This added longer time under anesthesia and the removal of the 2 parts of balloon was the extra part of the procedure that was not planned.
Additional Manufacturer Narrative
B5: describe event or problem: additional information.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 18459385
• Report Number: 2124215-2023-75370
• Device Sequence Number: 12560878
• Product Code: LIT
• UDI-Device Identifier: 08714729860136
• UDI-Public: 08714729860136
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: 04/06/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0029190717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 52 KG