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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 10/06/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: returned device consisted of a coyote es balloon catheter with blood in the balloon and wire lumen. The balloon was loosely folded. The tip, balloon, markerbands, and proximal weld were microscopically inspected. Functional testing was performed by connecting an inflation device filled with water to the hub. When pressure was applied, water was found to be leaking from the balloon. Inspection revealed a pinhole in the balloon material, located over the proximal edge of the proximal markerband. Microscopic inspection found the remainder of the device free of damage. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. 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 (b)(6) 2016. It was reported that crossing difficulties was encountered. The 100% stenosed target lesion was located in the moderately tortuous and severely calcified right superficial femoral artery (sfa). A 1. 5mm x 20mm x 143cm coyote¿ es balloon catheter was advanced but failed to cross the lesion. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was good. However, returned device analysis revealed 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
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key6119504
Report Number2134265-2016-10467
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 10/31/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/21/2016
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 NumberH74939135152010
Device Catalogue Number39135-15201
Device LOT Number19192415
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/12/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/28/2016
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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