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

Model Number 24700

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2024

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).

Event Description

It was reported that balloon rupture occurred.The 75% stenosed shunt was located in the severely tortuous and mildly calcified vessel.A 5.0mmx40mmx40cm (4f) sterling balloon was advanced for dilation.However, during the first inflation at 10 atmospheres for 60 seconds, the balloon ruptured.The device was removed and the procedure was completed with a different device.No complications were 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19093836
• MDR Text Key: 340107933
• Report Number: 2124215-2024-21108
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729122913
• UDI-Public: 08714729122913
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0033041594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2023
• 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