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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 H74939135354010
Device Problem Contamination (1120)
Patient Problem No Patient Involvement (2645)
Event Date 05/19/2017
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. Device evaluated by mfr: the device was not received for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).

 
Event Description

It was reported that product sterility was compromised. A 3. 5mm x 40mm x 146cm coyote¿ es balloon catheter was selected to treat the lesion. However upon pulling out the balloon that was tightly coiled from the hoop, the device "jumped off" or fell off from the table. The balloon was discarded after being contaminated and the procedure was completed with another of the same device. No patient complications were reported.

 
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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 Key6617374
MDR Text Key76837302
Report Number2134265-2017-05686
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK080982
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 05/19/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/24/2020
Device MODEL NumberH74939135354010
Device Catalogue Number39135-35401
Device LOT Number20562082
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/26/2017
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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