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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 H74939135204010
Device Problems Failure to Advance; Catheter
Event Date 07/10/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr: returned product consisted of a coyote es balloon catheter. The balloon was loosely folded. Te outer shaft, inner shaft, balloon and tip were microscopically examined. There are numerous hypotube and shaft kinks. The balloon has a pinhole at the distal markerband. Inspection of the remainder of the device presented no other damage or irregularities. 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 10-aug-2018. It was reported that crossing difficulties were encountered. The target lesion was located in the superficial femoral artery. A 2mm x 40mm x 145cm coyote¿ es balloon catheter was advanced for pre-dilatation. However, the device failed to cross the lesion despite several attempts. The procedure was completed with a non-bsc device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed 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
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key7851370
Report Number2134265-2018-07384
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 08/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939135204010
Device Catalogue Number39135-20401
Device LOT Number21832063
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/18/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/07/2018
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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