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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 H74939135303010
Device Problems Shaft; Break
Event Date 10/30/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that shaft break occurred. Vascular access was obtained via the groin and the pedal artery by retrograde approach. The target lesion was located in the superficial femoral artery (sfa). From the groin to the lesion, dilation was done with a 2. 5x100 otw coyote balloon catheter. From the pedal access site up to the lesion, a 3mmx30mmx145cm coyote es balloon catheter was advanced for dilatation. However, during procedure, the 3mmx30mmx145cm coyote es balloon catheter was sheared in half from the area that the wire exits the catheter on the monorail system. The sheared half remained inside the balloon catheter and was removed when the physician removed the system from the sheath. Nothing was left inside the patient. The physician just used the same 2. 5x100 otw coyote balloon previously used from the pedal approach. The physician then advanced a non bsc guidewire going from above and below the lesion. The procedure was completed with a different device. No patient complications were reported and the patient's status was fine.

 
Manufacturer Narrative

Device evaluated by mfr: returned device consisted of a coyote es balloon catheter with tight balloon folds, blood and contrast in the lumen and on the outside of the device. An unidentified guide wire was also returned with the complaint device. The returned wire was measured at. 01374 in. Microscopic inspection revealed a tear in the exchange port of the device, consistent with a wire tearing through the weld. Microscopic and tactile inspection found no irregularities or defects. Shaft of device was intact. 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 via the groin and the pedal artery by retrograde approach. The target lesion was located in the superficial femoral artery (sfa). From the groin to the lesion, dilation was done with a 2. 5x100 otw coyote balloon catheter. From the pedal access site up to the lesion, a 3mmx30mmx145cm coyote es balloon catheter was advanced for dilatation. However, during procedure, the 3mmx30mmx145cm coyote es balloon catheter was sheared in half from the area that the wire exits the catheter on the monorail system. The sheared half remained inside the balloon catheter and was removed when the physician removed the system from the sheath. Nothing was left inside the patient. The physician just used the same 2. 5x100 otw coyote balloon previously used from the pedal approach. The physician then advanced a non bsc guidewire going from above and below the lesion. 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¿ 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 Key5246101
Report Number2134265-2015-08000
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2017
Device MODEL NumberH74939135303010
Device Catalogue Number39135-30301
Device LOT Number17404731
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/23/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/31/2014
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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