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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 H74939134152010
Device Problems Failure to Advance; Catheter
Event Date 10/13/2016
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr. Returned device consisted of a coyote es balloon catheter with blood in the balloon and inflation lumen. The balloon, markerbands, tip, shaft and proximal weld were microscopically inspected. Inspection revealed a pinhole in the balloon material, located over the distal edge of the markerband. Inspection also found damage to the tip and kinks in the shaft 3cm and 66. 5cm from the tip of the device. Microscopic inspection found the remainder of the device free of damage. 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 (b)(6) 2016. It was reported that crossing difficulties were encountered. The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified anterior tibial artery (ata). A 1. 5mm x 20mm x 142cm coyote es balloon catheter was advanced but failed to cross the lesion. The device was removed and the procedure was completed with a 1. 2 x 20mm coyote fc balloon catheter. No patient complications were reported and the patient's status was good. However, returned device analysis revealed balloon pinhole.

 
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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 Key6149424
Report Number2134265-2016-10865
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 11/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/06/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2018
Device MODEL NumberH74939134152010
Device Catalogue Number39134-15201
Device LOT Number19224243
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/17/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/09/2016
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: 12/06/2016 Patient Sequence Number: 1
Treatment
GUIDEWIRE: JUPITER FC
GUIDING CATHETER: DESTENATION
INFLATION DEVICE: EVEREST
INTRODUCER SHEATH: MOSQUITO 5F
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