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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION COYOTE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24699
Device Problems Material Rupture; Failure to Advance
Event Date 08/08/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older.

 
Event Description

It was reported that balloon rupture occurred. The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee. After a non-bsc guide wire crossed the lesion, a 2. 0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation but it failed to cross. A 1. 5mm x 20mm x 143cm coyote es balloon catheter was then advanced but it ruptured at first inflation. It was replaced with another 1. 5mm x 20mm x 143cm coyote es balloon catheter which was able to dilate the lesion. Subsequently, dilation was again performed using the same 2. 0mm x 220mm x 150cm coyote balloon catheter but the balloon ruptured on the first inflation. Another 2. 0mm x 220mm x 150cm coyote balloon catheter was advanced; however, it also ruptured on the first inflation. The devices were completely removed, the physician used a 2mm x 40mm non-bsc balloon catheter to complete the procedure. No patient complications were reported and the patient's condition was stable.

 
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Brand NameCOYOTE
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove , MN 55311
6515827403
MDR Report Key7824318
Report Number2134265-2018-60503
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 08/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24699
Device Catalogue Number24699
Device LOT Number0021926797
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 Received08/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/29/2018
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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