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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 H74939185302210
Device Problems Shaft; Break
Event Date 11/08/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).  the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

Same case as mdr id 2134265-2017-11629. It was reported that shaft break occurred. The target lesion was located in the anterior tibial artery. When a 3. 0mm x 220mm x 150cm mr coyote¿ balloon catheter was loaded onto the guide wire, it was noted that the balloon was like "bound up" and grabbed hold of the wire and started to "accordion" and was broken. The device was removed and another 3. 0mm x 220mm x 150cm mr coyote¿ balloon catheter was advanced for dilation. However, during the first inflation at a nominal pressure, the balloon ruptured. The device was completely removed from the patient. The procedure was completed with a different device. No patient complications were reported and the patient's status was fine.

 
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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
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key7074958
Report Number2134265-2017-11630
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/08/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/01/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939185302210
Device Catalogue Number39185-30221
Device LOT Number0021251028
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/12/2017
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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