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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 Detachment Of Device Component; Tip
Event Type  Injury  
Manufacturer Narrative

Event date: (b)(6) 2018. (b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. Bsc id: (b)(4). Tw: (b)(4).

 
Event Description

It was reported via facility medwatch (b)(4) that tip detachment occurred. The target lesion was located in the anterior tibial artery. A 3mmx40mm x146cm coyote¿ es balloon catheter was inserted through the 6fr sheath and was extended down to the lesion. Prior to inflating the balloon, the tip of the device sheared off and was left in the vessel. The physician was able to snare the detached tip and was completely removed from the patient's body. No further 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 Key7515322
Report Number2134265-2018-03943
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/17/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939135304010
Device Catalogue Number39135-30401
Device LOT Number21722151
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 Received04/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/08/2018
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: 05/15/2018 Patient Sequence Number: 1
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