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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24701
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2019
Event Type  malfunction  
Event Description
It was reported that the catheter became entrapped on the guidewire.The 1.5mm x 20mm coyote balloon catheter became entrapped on the guidewire and could not be advanced or removed.The guidewire and balloon were removed together from the patient and there was still friction outside of the patient.The event was considered resolved, the procedure was completed with another device and the patient was stable following the procedure.
 
Event Description
It was reported that the catheter became entrapped on the guidewire.The 1.5mm x 20mm coyote balloon catheter became entrapped on the guidewire and could not be advanced or removed.The guidewire and balloon were removed together from the patient and there was still friction outside of the patient.The event was considered resolved, the procedure was completed with another device and the patient was stable following the procedure.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a coyote es balloon catheter that was loaded on an unknown guidewire.The inner shaft was buckled in two locations; however, measurement of the buckled locations was not possible due to the condition of the device.The wire was loaded in the catheter with 77.5cm sticking out of proximal end of the hub and distally 73.5cm from tip.The guidewire was unable to be removed due to the buckled locations of the inner shaft.The reported stuck on guidewire was confirmed.
 
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Brand Name
COYOTE ES
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9322582
MDR Text Key173340917
Report Number2134265-2019-13833
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729767329
UDI-Public08714729767329
Combination Product (y/n)N
PMA/PMN Number
K093636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24701
Device Catalogue Number24701
Device Lot Number0024066163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Date Manufacturer Received12/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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