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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 24706
Device Problem Inflation Problem (1310)
Patient Problem Insufficient Information (4580)
Event Date 05/01/2021
Event Type  Malfunction  
Manufacturer Narrative

Date of event: used the first day of the month of aware date, as event date was not provided. Device evaluated by mfr. : the 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 1cm from the tip. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis found damage that would have contributed to the failure to inflate.

 
Event Description

Reportable based on device analysis completed on 29jun2021. It was reported that balloon inflation failure occurred. A 2. 5mm x 220mm x 150cm coyote balloon catheter was advanced for dilation. During inflation, the balloon did not hold nominal pressure. The procedure was completed with another of same device. No patient complications were 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 Key12203260
MDR Text Key262674667
Report Number2134265-2021-09270
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 07/21/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24706
Device Catalogue Number24706
Device LOT Number0026687501
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/08/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/25/2021
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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