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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 24691
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/08/2019
Event Type  Injury  
Event Description
It was reported that balloon detachment occurred.The 100% stenosed target lesion was located in the severely calcified vessel below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during withdrawal, the balloon got separated.There was a balloon fragment left inside the body and the procedure was ended.No patient complications were reported.
 
Manufacturer Narrative
Outcomes attrib to adv event - changed from "other serious (important medical events)" to "required intervention to prevent permanent impairment or damage.".
 
Event Description
It was reported that balloon detachment occurred.The 100% stenosed target lesion was located in the severely calcified vessel below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during withrawal, the balloon got separated.There was a balloon fragment left inside the body and the procedure was ended.No patient complications were reported.It was further reported that the original plan was to conduct an amputation after a successful percutaneous transluminal angiography(pta) at the distal portion as much as possible.However, the detached portion lodged in the below-knee lesion and could not be retrieved.A major amputation was conducted after unsuccessful pta.The patient was followed-up in the hospital.
 
Manufacturer Narrative
Outcomes attrib to adv event: changed from "other serious (important medical events)" to "required intervention to prevent permanent impairment or damage".Device evaluated by mfr.: the returned complaint device consisted of a portion of the distal shaft, balloon and tip of a coyote es balloon catheter.The balloon is broken but attached to the device.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The hub, hypotube and the proximal end of the shaft were not returned.There are multiple kinks along the whole device shaft.The shaft is buckled and stretched in numerous locations.The balloon is completely circumferentially torn about 9.5 mm from the proximal balloon weld.The distal portion of the broken balloon is prolapsed distally over the tip.There is about 10mm of balloon material on the distal portion of the balloon.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that balloon detachment occurred.The 100% stenosed target lesion was located in the severely calcified vessel below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during withdrawal, the balloon got separated.There was a balloon fragment left inside the body and the procedure was ended.No patient complications were reported.It was further reported that the original plan was to conduct an amputation after a successful percutaneous transluminal angiography(pta) at the distal portion as much as possible.However, the detached portion lodged in the below-knee lesion and could not be retrieved.A major amputation was conducted after unsuccessful pta.The patient was followed-up in the hospital.It was further reported that when the balloon was initially delivered it would not reach the lesion.It was then delivered again together with a non-bsc guide extension catheter, it did reach the lesion, however, the balloon would not inflate due to suspected shaft kink.The patient current condition is stable.
 
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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 Key8566126
MDR Text Key143595172
Report Number2134265-2019-04533
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729767169
UDI-Public08714729767169
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,distri
Type of Report Initial,Followup,Followup
Report Date 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Model Number24691
Device Catalogue Number24691
Device Lot Number0019402393
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2019
Date Manufacturer Received05/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE EXTENSION CATHETER: GUIDELINER
Patient Outcome(s) Other; Required Intervention;
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