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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 H74939135202010
Device Problems Failure to Advance; Catheter
Event Date 06/04/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr: returned product consisted of coyote es balloon catheter. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. There was a pinhole in the balloon material at the proximal markerband. Microscopic examination of the balloon presented no irregularities in the balloon material or the ro marker that could have contributed to the pinhole. There were numerous kinks throughout the hypotube. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

 
Event Description

Reportable based on device analysis completed on 29-jun-2018. It was reported that crossing difficulties were encountered. The stenosed target lesion was located in the vessel below the knee. A 2mm x 20mm x 143cm coyote¿ es balloon catheter was advanced for pre-dilatation but failed to cross the lesion. Subsequently, the device was again advanced through a non-bsc guide extension catheter but it still failed to cross. The procedure was completed with a different device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed a pinhole in the balloon material.

 
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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
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key7700376
Report Number2134265-2018-06463
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 06/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939135202010
Device Catalogue Number39135-20201
Device LOT Number21871810
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/11/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/16/2018
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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