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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 H74939135304010
Device Problems Failure to Advance; Catheter
Event Date 03/27/2017
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. The balloon was loosely folded. There was contrast in the inflation lumen. The outer shaft, inner shaft, balloon and tip were microscopically examined. There were numerous hypotube kinks. There was tip damage. The core wire was protruding through the distal shaft. The exit notch was torn. A longitudinal tear was identified in the balloon wall. There was no evidence of any material or manufacturing deficiencies contributing to the damage. There was no evidence of any damage or irregularities contributing to the reported crossing difficulty, which could not be confirmed because the clinical circumstances could not be replicated. Inspection of the remainder of the device presented 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 13-apr-2017. It was reported that crossing difficulties were encountered. The 100% stenosed target lesion was located in the moderately tortuous and severely calcified anterior tibial artery (ata). A 3mm x 40mm x 146cm coyote¿ es balloon catheter was advanced but failed to cross the lesion. The device was completely removed from the patient and the procedure was completed with a 1. 5 x 40 sterling es (coyote es mr). No patient complications were reported and the patient's status was good. However, returned device analysis revealed shaft hole/perforation and balloon longitudinal tear.

 
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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 Key6540608
Report Number2134265-2017-04163
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 04/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2019
Device MODEL NumberH74939135304010
Device Catalogue Number39135-30401
Device LOT Number19294464
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/31/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/24/2016
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: 05/03/2017 Patient Sequence Number: 1
Treatment
GUIDE CATHETER: DESTINATION 6F
GUIDE WIRE: JUPITER
INFLATION DEVICE: EVEREST
INTRODUCER SHEATH: MEDKIT 4F
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