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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 H74939135402010
Device Problems Shaft; Break
Event Date 02/16/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that shaft break occurred. Vascular access was obtained bidirectionally with anterograde approach. The 99% stenosed, 17cm long target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa). After a guidewire crossed the lesion, a 4x20 sterling balloon catheter was advanced for pre-dilatation. A 4mmx20mmx144cm coyote¿ es balloon catheter was advanced for post dilation. However, during procedure, the shaft broke and remained on the guide wire. The balloon was withdrawn together with the guidewire with no remnant found inside the patient and the procedure was completed. No patient complications were reported and the patient's status was good.

 
Manufacturer Narrative

Device evaluated by mfr. : returned device consisted of a coyote es balloon catheter with blood in the balloon and lumen. The balloon was loosely folded. There was damage (twisted) to the port/exit notch. Microscopic and tactile inspection revealed numerous kinks in the hypotube. The outer shaft was separated 35cm from the tip of the device. 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

It was reported that shaft break occurred. Vascular access was obtained bidirectionally with anterograde approach. The 99% stenosed, 17cm long target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa). After a guidewire crossed the lesion, a 4x20 sterling balloon catheter was advanced for pre-dilatation. A 4mmx20mmx144cm coyote es balloon catheter was advanced for post dilation. However, during procedure, the shaft broke and remained on the guide wire. The balloon was withdrawn together with the guidewire with no remnant found inside the patient and the procedure was completed. No patient complications were reported and the patient's status was good.

 
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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
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5500858
Report Number2134265-2016-01597
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/15/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/02/2017
Device MODEL NumberH74939135402010
Device Catalogue Number39135-40201
Device LOT Number17018931
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/04/2014
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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