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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION COYOTE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24704
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a coyote balloon catheter. The outer shaft, inner shaft, balloon and tip were visually and microscopically examined. Visual examination revealed no damages. Microscopic examination revealed a pinhole in the balloon 8mm from the tip. Inspection of the remainder of the device presented no other damage or irregularities.

 
Event Description

Reportable based on device analysis completed on 10june2021. It was reported that balloon inflation failure occurred. The target lesion was located in the lower extremity vessel. A 2. 0mm x 60mm x 150cm coyote balloon catheter was advanced for dilation but the balloon would not inflate. The device was removed and the procedure was completed with another of the same device. There were no patient complications reported. However, returned device analysis revealed balloon pinhole.

 
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Brand NameCOYOTE
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12094389
MDR Text Key259377392
Report Number2134265-2021-08108
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/30/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24704
Device Catalogue Number24704
Device LOT Number0024884541
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/20/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/06/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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