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

Model Number 24716

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/30/2020

Event Type  Injury  

Event Description

It was reported that balloon rupture and balloon detachment occurred. The target lesion was located in the heavily calcified left superficial femoral artery. A 6. 0x220x150 sterling balloon catheter was advanced for dilatation. However, during the second inflation, the balloon ruptured circumferential and a piece of the balloon remained in the patient. The procedure took an extra three hours of trying to remove the piece of the balloon by snare and also a non-bsc filter wire that sheared off in the heavily calcified lesion. The fragmented piece had to be left in the patient and a covered stent was deployed to jail it up against the wall. The filter wire also tried to be retrieved and was unsuccessful, so it was jailed up against the wall along with the balloon fragment. There were no further complications reported.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9943481
• MDR Text Key: 187060834
• Report Number: 2134265-2020-04724
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/08/2021
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0025187239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/09/2020 Patient Sequence Number: 1