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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC COYOTE BALLOON

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BOSTON SCIENTIFIC COYOTE BALLOON Back to Search Results
Model Number COYOTE
Device Problems Wire (430); Activation, Positioning or SeparationProblem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2014
Event Type  Malfunction  
Event Description

A 3. 5 x 100mm coyote over the wire balloon used to treat a lesion in the left leg below the knee. We decided to change wires to advance the system further so an attempt to change the wires out was made. The new 0. 014 wire would not insert and pass beyond the hub of the balloon. Not even the stiff side of the wire would pass. In order to save placement and get a wire down into the far side of the lesion we had to cut the hub off and we were successful at placing the new wire distal to the lesion and retrieving the balloon shaft back out of the body.

 
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Brand NameCOYOTE
Type of DeviceBALLOON
Manufacturer (Section D)
BOSTON SCIENTIFIC
maple grove 55311
MDR Report Key3952632
MDR Text Key4643030
Report NumberMW5037351
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/17/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/01/2015
Device MODEL NumberCOYOTE
Device Catalogue NumberH74939186351010
Device LOT Number15289832
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes

Patient TREATMENT DATA
Date Received: 07/18/2014 Patient Sequence Number: 1
Treatment
6 FR ANSEL 1; 300CM CONFIENTA PRO 12; 300CM SPARTACORE
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