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

Model Number 24715

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in a severely tortuous and severely calcified vein.A 5.0x150x90mm sterling balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres for 10 seconds, the balloon ruptured.A pinhole was noticed in the balloon.The device was safely removed from the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in a severely tortuous and severely calcified vein.A 5.0x150x90mm sterling balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres for 10 seconds, the balloon ruptured.A pinhole was noticed in the balloon.The device was safely removed from the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.It was further reported that the target lesion was located in the iliac vein.After the sterling balloon was ruptured, a 7.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 20 atmospheres for 10 seconds, the balloon also ruptured.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11222940
• MDR Text Key: 228436400
• Report Number: 2134265-2021-00708
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K132430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

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: 24715
• Device Catalogue Number: 24715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1