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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 H74939135152010
Device Problems Failure to Advance; Catheter
Event Date 03/01/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: returned product consisted of a coyote es balloon catheter. There was contrast and blood in the inflation lumen and balloon. The balloon was loosely folded. Microscopic examination of the balloon revealed no damage. 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 at the distal end of the markerband was revealed. There was a scratch to the left of the pinhole. Microscopic examination presented no irregularities in the balloon material that could have contributed to the damage. 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 16-march-2016. It was reported that crossing difficulties were encountered. The 100% stenosed target lesion was located in the severely calcified vessel below the knee. A 1. 5mm x 20mm x 143cm 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 a balloon pinhole.

 
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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
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5551616
Report Number2134265-2016-02610
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 03/16/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/06/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2018
Device MODEL NumberH74939135152010
Device Catalogue Number39135-15201
Device LOT Number17955071
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 Received03/16/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/07/2015
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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