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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 H74939186202210
Device Problems Failure to Advance; Catheter
Event Date 02/24/2017
Event Type  Malfunction  
Manufacturer Narrative

Age at the time of event: 18 years or older. (b)(4). Device evaluated by mfr. : returned product consisted of a coyote balloon catheter with a stopcock attached to the hub. The shaft, tip, markerbands, and balloon were microscopically and visually examined. There was blood in the inflation lumen. The balloon was loosely folded. Microscopic examination of the balloon revealed no damage. The tip was damaged. 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. The balloon was microscopically examined and a pinhole in the balloon wall 3mm from the proximal end of the distal markerband was revealed. Microscopic examination presented no irregularities in the balloon material or markerbands that could have contributed to the damage. 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 analysis completed on 16-mar-2017. It was reported that crossing difficulties were encountered. The 100% stenosed target lesion was located in the moderately tortuous and severely calcified anterior tibial artery (ata). After a non-bsc guidewire crossed the lesion, a 2. 0mm x 220mm x 150cm coyote¿ balloon catheter was advanced but failed to cross the lesion. The procedure was completed with a 1. 5-20x142 coyote¿ balloon catheter. No patient complications 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 Key6458130
Report Number2134265-2017-02737
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 03/16/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/04/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2019
Device MODEL NumberH74939186202210
Device Catalogue Number39186-20221
Device LOT Number19150129
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/03/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/20/2016
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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