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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 H74939135404010
Device Problems Failure to Advance; Catheter
Event Date 08/09/2016
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 and contrast in the inflation lumen and balloon. The tip and balloon were examined. The balloon was loosely folded. The tip was damaged. There was a tear in the inner and outer shaft material at the guide wire exit notch which extended 8 cm distally. The damage is consistent with the guide wire tearing through the shaft. There were numerous hypotube kinks. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty. 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 08-sep-2016. It was reported that crossing difficulties were encountered. The 95% target lesion was located in the moderately tortuous and moderately calcified vessel below the knee. A 4mmx40mmx146cm coyote es balloon catheter was advanced but failed to cross the lesion. The procedure was completed with a peripheral cutting balloon (pcb). No patient complications were reported and the patient's status was good. However, returned device analysis revealed a shaft hole/ perforation.

 
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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 Key5992469
Report Number2134265-2016-08645
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 09/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/12/2017
Device MODEL NumberH74939135404010
Device Catalogue Number39135-40401
Device LOT Number16965891
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/26/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/14/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/30/2016 Patient Sequence Number: 1
Treatment
GUIDEWIRE: COMMED
INFLATION DEVICE: KANEKA
INTRODUCER SHEATH:PARENT
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