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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939185252210
Device Problems Failure to Advance; Catheter
Event Date 06/14/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: returned product consisted of a coyote balloon catheter with a stopcock attached to the hub. The balloon was loosely folded with blood in the hub, balloon, inflation lumen and wire lumen. The device was soaked in a warm waterbath for 5 days. The tip, balloon, markerband, inner/outer shaft (lumen) were microscopically, tactile and visually inspected. Inspection revealed a pinhole in the balloon material located 11. 5cm proximally from the distal markerband. Inspection of the remainder of the device, apart from the observed damage, revealed 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 19-aug-2018. It was reported that crossing difficulties were encountered. The target lesion was located in a vessel below the knee. A 2. 5mm x 220mm x 150cm coyote¿ balloon catheter was advanced but failed to cross the lesion. The procedure was completed with a 2. 0mm x 20mm x 150cm coyote¿ balloon catheter. No patient complications nor injuries were reported. However, returned device analysis revealed balloon pinhole.

 
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Brand NameCOYOTE¿
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 Key7876850
Report Number2134265-2018-07430
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 08/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939185252210
Device Catalogue Number39185-25221
Device LOT Number0021514664
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/17/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/14/2017
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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