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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 H74939135404010
Device Problems Failure to Advance; Catheter
Event Date 06/19/2018
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 with blood in the lumen and balloon. The outer shaft, inner shaft, balloon and tip were microscopically examined. The tip is damaged. There is a 21mm longitudinal balloon tear 18mm from the proximal markerband. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any damage or irregularities contributing to the damage and reported crossing difficulty. The investigation conclusion is operational context as the product meets the design and 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 (b)(6) 2018. It was reported that crossing difficulties were encountered. The target lesion was located in the superficial femoral artery. A 4mm x 40mm x 146cm coyote es balloon catheter was advanced but failed to cross the lesion. The procedure was completed with a different device. No patient complications were reported and the patient's status was good. However, returned device analysis revealed balloon torn longitudinally.

 
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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 Key7787131
Report Number2134265-2018-07314
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 07/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939135404010
Device Catalogue Number39135-40401
Device LOT Number22020613
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/27/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/21/2018
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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