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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 Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem No Code Available (3191)
Event Date 10/11/2018
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that removal difficulty was encountered and shaft break occurred.Vascular access was obtained using ipsilateral retrograde approach.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified iliac vessel.A 4fr introducer and a non-bsc guide wire were passed through radial approach respectively.A 4mm x 40mm x 146cm coyote es balloon catheter was used for dilatation.The balloon was deflated but upon removing the device, the device was trapped with the wire at the upper arm.The devices were removed with excessive force together as a unit and it was noted that the guide wire accordianed.However, it was noticed that 20cm from the tip of the balloon got detached and remained inside the body.The patient was then sent for surgery and the broken fragment was successfully removed.An epic stent was deployed in the target lesion.No further patient complications were reported.
 
Event Description
It was reported that removal difficulty was encountered and shaft break occurred.Vascular access was obtained using ipsilateral retrograde approach.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified iliac vessel.A 4fr introducer and a non-bsc guide wire were passed through radial approach respectively.A 4mm x 40mm x 146cm coyote es balloon catheter was used for dilatation.The balloon was deflated but upon removing the device, the device was trapped with the wire at the upper arm.The devices were removed with excessive force together as a unit and it was noted that the guide wire accordianed.However, it was noticed that 20cm from the tip of the balloon got detached and remained inside the body.The patient was then sent for surgery and the broken fragment was successfully removed.An epic stent was deployed in the target lesion.No further patient complications were reported.Device evaluated by manufacturer: the returned product consisted of a coyote es balloon catheter with a stopcock,.014" guide wire, and introducer sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube is separated 26.5cm from the tip and appears to be stretched prior to separation.There are multiple kinks along the whole device.Microscopic examination revealed a circumferential tear 10mm from the tip.There is blood present in the inflation lumen and balloon.The balloon is loosely folded.Review of the product specification indicates that all device models must be compatible with 4f introducer sheaths.The guidewire that returned with the balloon was inserted into the introducer sheath that also came back with the balloon.Then the separated distal section of the balloon was functionally tested and the balloon could follow the guidewire through the introducer sheath without any resistance.Inspection of the remainder of the device presented no other damage or irregularities.
 
Manufacturer Narrative
Age at time of event: 18 years or older.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/13/2018 11:01 am ct.The report number is being corrected from: 2134265-2018-63919 to: 2134265-2018-62562.
 
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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 Key8037524
MDR Text Key126093273
Report Number2134265-2018-62562
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729767312
UDI-Public08714729767312
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
Report Date 01/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/25/2020
Device Model Number24691
Device Catalogue Number24691
Device Lot Number0020817316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2018
Date Manufacturer Received11/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE WIRE: TREASURE FLOPPY; GUIDE WIRE: TREASURE FLOPPY; GUIDE WIRE: TREASURE FLOPPY
Patient Outcome(s) Required Intervention;
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