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

Model Number 24690

Device Problem Material Rupture (1546)

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.Patient underwent a percutaneous transluminal angioplasty.The 100% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 6.0mmx60mmx135cm (4f) sterling balloon catheter was advanced for dilation.During procedure, on the 2nd inflation at 14 atmospheres for 60 seconds, the balloon ruptured in a horizontal form.Physician noted that the rupture may have occurred due to the force applied as the lesion was calcified and eccentric.The device was replaced for a different model to complete the procedure.No complications reported, and patient status was stable.

• 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: 18988235
• MDR Text Key: 338729610
• Report Number: 2124215-2024-18386
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729757313
• UDI-Public: 08714729757313
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141150
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0032875343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2023
• 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