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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 07/03/2015
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 blood in the inflation lumen and balloon. The balloon was loosely folded. Microscopic examination revealed a pinhole in the balloon wall on the proximal edge of the markerband. Microscopic examination presented no irregularities in the balloon material that could have contributed to the damage. Microscopic examination presented no damage or irregularities to the tip. 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

Reportable based on device analysis completed on (b)(4) 2015. It was reported that crossing difficulties were encountered. Vascular access was obtained via the right femoral artery. The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified right posterior tibial artery. A 4. 5f non bsc introducer sheath was placed. After a non bsc guide wire crossed the lesion, a 1. 5mm x 20mm x 143cm coyote es balloon catheter was advanced but was unable to cross the lesion. The device was exchanged to a 1. 5mm x 2mm non bsc balloon catheter which was inflated at 8 atmospheres. Additional dilation was then performed at 8 atmospheres using a 2. 5mm x 15mm coyote balloon catheter and the procedure was completed. No patient complications were reported and the patient' 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
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5042379
Report Number2134265-2015-05731
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 08/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/08/2016
Device MODEL NumberH74939135152010
Device Catalogue Number39135-15201
Device LOT Number16596281
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/08/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/11/2013
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: 08/31/2015 Patient Sequence Number: 1
Treatment
INFLATION DEVICE: EVEREST
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