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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 Failure to Advance; Catheter
Event Date 09/09/2016
Event Type  Malfunction  
Manufacturer Narrative

Age at the time of event: 18 years or older. Device evaluated by mfr: returned product consisted of a coyote balloon catheter. The balloon was loosely folded with blood in the balloon and lumen. The tip, balloon, and markerbands were microscopically inspected. Inspection revealed a burst in the balloon material, 63mm in length. 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 28-sep-2016. It was reported that crossing difficulties were encountered. The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. A 4. 0mmx150mmx150cm coyote¿ 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 longitudinal balloon tear.

 
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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 Key6058982
Report Number2134265-2016-09314
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 09/28/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/26/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/27/2017
Device MODEL NumberH74939185401510
Device Catalogue Number39185-40151
Device LOT Number17156458
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/13/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/30/2014
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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