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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 24690
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2019
Event Type  Malfunction  
Manufacturer Narrative

Initial reporter address 1: (b)(6).

 
Event Description

It was reported that balloon rupture occurred. The 100% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery. After a non-bsc guidewire was passed through, a 4. 0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation. However, on the first inflation at 14 atmospheres , the balloon ruptured. The device was removed and another 4. 0mm x 220mm x 150cm coyote balloon catheter was selected; however it also ruptured after being inflated at 14 atmospheres. A non-bsc balloon catheter was advanced for dilatation and after placing an eluvia stent, post-dilatation was performed with a 6. 0mmx150mmx150cm (4f) sterling balloon catheter. The sterling balloon ruptured during its first inflation at 12 atmospheres. The procedure was successfully completed with no patient complications reported.

 
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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 Key9481953
MDR Text Key176484796
Report Number2134265-2019-15743
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK141150
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 12/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/24/2021
Device MODEL Number24690
Device Catalogue Number24690
Device LOT Number0024183385
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/29/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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