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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 H74939135302010
Device Problems Shaft; Kinked
Event Date 01/16/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: returned product consisted of a coyote es balloon catheter with no other devices. There was blood in the wire lumen. The hypotube shaft was completely separated 64cm from the hub. The fracture faces were oval as if kinked prior to separation. The shaft was torn at the guidewire exit notch. The tear is consistent with a guidewire or mandrel ripping through the shaft. The tip was damaged. Inspection of the remainder of the device presented no other damage or irregularities. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

 
Event Description

Reportable based on device analysis completed on 30-jan-2018. It was reported that shaft kink occurred. A y-90 treatment was performed. The target lesion was located in the left hepatic artery. A 3mm x 20mm x 144cm coyote¿ es balloon catheter was advanced to block the backflow of the left hepatic artery; to inject the y-90 treatment. The physician was already informed by the sales representative that using the device was off label for the treatment performed. The device was then removed completely from the patient; however, kink on the catheter was noted. Normal algorithm of y-90 was followed and the treatment went fine. The procedure was completed just normal without using any type of balloon catheter. No patient complications were reported and the patient's status was fine. However, returned device analysis revealed hypotube break and outer shaft hole.

 
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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 Key7290152
Report Number2134265-2018-01061
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939135302010
Device Catalogue Number39135-30201
Device LOT Number21485675
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/07/2017
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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