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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 H74939135152010
Device Problems Failure to Advance; Catheter
Event Date 10/18/2016
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr: returned product consisted of a coyote es balloon catheter. There was contrast and blood in the inflation lumen and balloon. The shaft, balloon, and tip were microscopically examined. There were numerous locations with buckling of the shaft and under the balloon. The balloon was bunched up. The distal tip was damaged. Functional testing was performed by attaching an inflation device filled with water to the device. When positive pressure was applied, a stream of water emitted from the shaft wall. The shaft was microscopically examined and a hole in the shaft wall 5. 3cm distal of the exit notch was revealed. Microscopic examination presented no irregularities in the shaft material that could have contributed to the damage. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. No other issues were identified during the product analysis. 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 09-nov-2016. It was reported that crossing difficulties were encountered.    the 100% stenosed target lesion was located in the moderately tortuous and severely calcified peroneal artery. A 1. 5mm x 20mm x 143cm coyote¿ es balloon catheter was advanced for dilation but failed to cross the lesion. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was good. However, returned device analysis revealed 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 Key6129102
Report Number2134265-2016-10779
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 11/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2019
Device MODEL NumberH74939135152010
Device Catalogue Number39135-15201
Device LOT Number19192415
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/26/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/28/2016
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: 11/28/2016 Patient Sequence Number: 1
Treatment
GUIDEWIRE: JUPITER
INFLATION DEVICE: BOSTON
INTRODUCER SHEATH: MEDIKIT
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