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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939135152010
Device Problems Failure to Advance; Catheter
Event Date 06/25/2015
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. Device evaluated by mfr: returned product consisted of coyote es balloon catheter. The balloon was loosely folded. There was blood in the inflation lumen and wire lumen. The outer shaft, inner shaft, balloon and tip were microscopically examined. There was a pinhole in the balloon material at the markerband. Microscopic examination of the balloon presented no irregularities in the balloon material or markerbands that could have contributed to the damage. There were numerous hypotube kinks. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).

 
Event Description

Reportable based on device analysis completed on 13-aug-2015. It was reported that crossing difficulties were encountered. The chronic totally occluded (cto) target lesion was located in the bilateral iliac arteries. After a guide wire crossed the lesion, a 1. 5mmx20mmx143cm coyote¿ es balloon catheter was advanced but failed to cross the lesion. The device was removed and the procedure was completed with a coyote fc balloon catheter. No patient complications were reported and the patient¿s status was good. However, returned device analysis revealed a balloon pinhole.

 
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Brand NameCOYOTE¿ ES
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5063689
Report Number2134265-2015-05921
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 08/13/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2018
Device MODEL NumberH74939135152010
Device Catalogue Number39135-15201
Device LOT Number17611384
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/06/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/17/2015
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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