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 12/18/2020

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in a non-tortuous and moderately calcified vessel in a lower extremity.A 6.0 x 150 x 150 sterling balloon catheter was advanced for dilatation.However, during the first inflation at 10 atmospheres for 90 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.

Manufacturer Narrative

Device evaluation by mfr: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.There was a longitudinal tear 25mm long starting at the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in a non-tortuous and moderately calcified vessel in a lower extremity.A 6.0 x 150 x 150 sterling balloon catheter was advanced for dilatation.However, during the first inflation at 10 atmospheres for 90 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11158655
• MDR Text Key: 226565096
• Report Number: 2134265-2021-00252
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729845447
• UDI-Public: 08714729845447
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0025102678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1