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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 02/25/2016
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 balloon catheter in two pieces with an unidentified. 014¿ guidewire in the distal portion of the catheter. The guidewire was protruding 36. 5cm from the inner separation and 178. 5cm from the tip. There was blood in the balloon. The balloon was tightly folded. Microscopic examination revealed that the balloon had a complete circumferential tear at the right side of the proximal markerband (4cm distal of the proximal balloon transition). Microscopic examination presented no damage or irregularities in the markerbands. Microscopic examination presented no damage or irregularities in the bonds. Microscopic examination revealed that the inner shaft was detached at the exit notch. The separated ends of the inner appeared to be jagged and damaged, which indicates that the separation was due to tensile overload. Majority of the inner shaft was stretched and buckled. An attempt was made to remove the guidewire from the inner shaft; however, due to the damage to the shaft the guidewire was unable to be removed. Microscopic examination revealed that the tip was damaged. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. No other issues were identified during the product analysis. 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 (b)(4) 2016. It was reported that crossing difficulties were encountered. The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee. A 2. 5mmx220mmx150cm, mr coyote balloon catheter was advanced for dilation; however, the device was not able 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 catheter froze on wire, circumferential balloon tear and shaft detached/separated.

 
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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
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5609963
Report Number2134265-2016-03073
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 03/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/26/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/28/2016
Device MODEL NumberH74939185252210
Device Catalogue Number39185-25221
Device LOT Number16493469
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/07/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2013
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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