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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, PERCUTANEOUS Back to Search Results
Model Number 24716
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Twisted/Bent (2981)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/03/2020
Event Type  Injury  
Event Description

It was reported that multiple issues had occurred in the duration of a procedure. A procedure was being performed, 95% stenosed target lesion was located in the severely calcified and mildly tortuous proximal area of the right superior femoral artery. A 6 x 200 x 90 hybrid sterling balloon catheter was being used. The physician had felt some resistance during insertion of the balloon, but it was noted that there was a lot of calcification. The balloon was able to be advanced to the targeted site. The physician inflated the balloon at nominal pressure and was described as not being well deployed. The pressure was increased to about twelve atmospheres, at which point it was said to be well deployed but that there was a "hiccup" in the proximal area. At that point, the physician believes that the balloon ruptured and broke. After the dilatation, the balloon was removed. Once it was outside the patient they saw that a part of the balloon was missing. It was attempted to remove the part from the patient by snaring, but this failed. The physician stated that the patient was okay immediately after the procedure. No pain or complications and the patient was discharged the next day. The physician said that these vessels were already in very bad condition before this procedure, that therefore this issue didn't cause any additional problems for the patient.

 
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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 Key10174529
MDR Text Key195760174
Report Number2134265-2020-08220
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberK132430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24716
Device Catalogue Number24716
Device LOT Number0024541622
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/23/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/04/2019
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: 06/19/2020 Patient Sequence Number: 1
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