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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 H74939135404010
Device Problems Shaft; Break
Event Date 09/25/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Returned product consisted of the hypotube and shaft of a coyote es balloon catheter in two pieces, the hub not received. The shaft, hypotube, and bonds were microscopically and visually examined. There is tip damage. The shaft was completely separated 26. 5cm from the tip. As the shaft is completely circumferentially torn it is consistent with the reported damage. There are numerous hypotube and shaft kinks. There is no evidence that the device failed to meet applicable product specifications prior to shipment. The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors. (b)(4).

 
Event Description

It was reported that shaft break occurred. The target lesion was located in the tibial artery. A 4mmx40mmx146cm coyote¿ es balloon catheter was advanced for dilation. However during procedure, the balloon broke with a "c" tear. No patient complications were reported.

 
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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
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key6945224
Report Number2134265-2017-10098
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2019
Device MODEL NumberH74939135404010
Device Catalogue Number39135-40401
Device LOT Number09/25/2017
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/29/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2016
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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