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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 H74939185401510
Device Problems Shaft; Kinked; Failure to Advance; Catheter
Event Date 04/01/2016
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4). Device evaluated by manufacturer: returned product consisted of a coyote balloon catheter. There was blood in the inflation lumen and balloon. Microscopic examination and tactile inspection revealed numerous kinks in the shaft of the device. The balloon was loosely folded. Microscopic examination of the balloon presented no damage or irregularities. Functional testing was performed by attaching an inflation device filled with water to the device. When positive pressure was applied, a stream of water emitted from the balloon wall 5. 5cm proximal of the distal markerband. The balloon was microscopically examined and a pinhole in the balloon wall was revealed. Microscopic examination presented no irregularities in the balloon material that could have contributed to the damage. Microscopic examination and tactile inspection presented no damage or irregularities to the core wire. Microscopic examination presented no damage or irregularities to the markerbands. Microscopic examination presented no damage or irregularities to the bonds. Microscopic examination presented no damage or irregularities to the distal tip. Inspection of the remainder of the device, apart from the observed damage, presented 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 29-apr-2016. It was reported that shaft kink occurred and crossing difficulties were encountered. The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa). A 4. 0mm x 150mm x 150cm coyote¿ balloon catheter was advanced for dilatation. However, the shaft was kinked and the device failed to cross the lesion. The procedure was completed with a non-bsc balloon catheter. No patient complications were encountered and the patient's status was good. However, returned device analysis revealed a 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
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5680368
Report Number2134265-2016-04397
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 04/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/07/2017
Device MODEL NumberH74939185401510
Device Catalogue Number39185-40151
Device LOT Number16954885
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/08/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/13/2014
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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