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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE PTA BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION COYOTE PTA BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number H74939186201510
Device Problems Fracture (1260); Difficult to Remove (1528); Material Rupture (1546); Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 08/06/2021
Event Type  Malfunction  
Event Description

Approximately 1 minute into insufflation, the balloon ruptured (inflation pressure was at 11 mmhg). While attempting to extract the balloon and the wire for angiogram, it was then found that the v 14th wire tip at the fractured, and stuck at the junction of the plantar arteries in the posterior tibial artery. Significant effort was then spent with the next approximately 2 hours attempting to extract the wire fragment. Attempt was first made with 3. 2 french ensnare. We were ultimately able to capture the wire fragment and the fragment was retracted to the distal sfa level, however then excluded from the snare and embolized into the dorsalis pedis. Access into the dorsalis pedis was gained, and we were successfully able to aspirate the wire fragment using the indigo aspiration catheter.

 
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Brand NameCOYOTE PTA BALLOON DILATATION CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12318030
MDR Text Key266407472
Report Number12318030
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/11/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939186201510
Device LOT Number27347949
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2021
Event Location Hospital
Date Report TO Manufacturer08/13/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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