• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, PERCUTANEOUS Back to Search Results
Model Number 24700
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2021
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling balloon catheter. The outer shaft, inner shaft, balloon and tip were visually and microscopically examined. Visual examination revealed no damages. Microscopic examination revealed a pinhole 48mm from the tip. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis confirmed there is a rupture in the balloon which would contribute to the balloon to failure to inflate.

 
Event Description

Reportable based on device analysis completed on 16jun2021. It was reported that balloon inflation failure occurred. The 90% stenosed target lesion was located in the moderately tortuous forearm vein. A 5. 0mmx40mmx40cm sterling balloon catheter was advanced for dilatation. However, during inflation, pressure would not increase and the balloon failed to inflate. The procedure was completed with another of the same device. There were no patient complications nor injuries reported. However, returned device analysis revealed balloon pinhole.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTERLING
Type of DeviceCATHETER, 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 Key12125188
MDR Text Key260219474
Report Number2134265-2021-08321
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK053116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 07/06/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/06/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24700
Device Catalogue Number24700
Device LOT Number0026740064
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/25/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/02/2021
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-