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

Model Number 24700

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/22/2023

Event Type  Injury  

Event Description

It was reported that balloon rupture, removal difficulties, and material separation occurred resulting to an unretrieved device fragment.The patient underwent shunt percutaneous transluminal angioplasty.The 95% stenosed target lesion was located in the mildly calcified artery.A 6.0mmx40mmx40cm (4f) sterling balloon catheter was advanced for dilation.However, during the second inflation at 20 atmospheres, the balloon ruptured.During removal of the device, resistance was felt, and force was applied.The device was somehow removed, but a part of damaged device remained inside the patient.The procedure was completed with different device.There were no patient complications reported, and the patient was in good condition post procedure.

• Brand Name: STERLING
• Type of Device: 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16897443
• MDR Text Key: 314854425
• Report Number: 2124215-2023-18034
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729123781
• UDI-Public: 08714729123781
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0029912259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other