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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 H74939134254010
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Same case as mdr id 2134265-2015-08147.It was reported that catheter entrapment occurred.The 90% stenosed, tight target lesion was located in the non-tortuous and moderately calcified left tibial artery.A v-14 control wire guide wire was used then a 2.5mm x 40mm x 145cm coyote¿ es balloon catheter was advanced to the lesion.Dilation was performed and when an attempt was made to pull the balloon catheter back off the guide wire, the balloon catheter became stuck on the wire.Both the balloon catheter and the guide wire were removed as a unit and the procedure was completed.No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
Device evaluated by mfr: returned device consisted of a coyote es balloon catheter with contrast in the balloon.The balloon was loosely folded.Microscopic inspection found no irregularities or damage to the tip of the device.Microscopic inspection found no irregularities with the bond of the device.The inner diameter (id) of the wire lumen was measured at both ends with a calibrated pin gauge set, which is within specification.Microscopic inspection revealed numerous kinks in the distal shaft and the inner shaft.Functional testing was completed using a kinetix plus guide wire as the guide wire used in the clinical event was not returned for analysis.The kinetix guide wire loaded fine, but could not advance through the kinks in the shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
Same case as mdr id 2134265-2015-08147.It was reported that catheter entrapment occurred.The 90% stenosed, tight target lesion was located in the non-tortuous and moderately calcified left tibial artery.A v-14 control wire guide wire was used then a 2.5mm x 40mm x 145cm coyote¿ es balloon catheter was advanced to the lesion.Dilation was performed and when an attempt was made to pull the balloon catheter back off the guide wire, the balloon catheter became stuck on the wire.Both the balloon catheter and the guide wire were removed as a unit and the procedure was completed.No patient complications were reported and the patient's status was fine.
 
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Brand Name
COYOTE¿ ES
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5260489
MDR Text Key32479144
Report Number2134265-2015-08143
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2017
Device Model NumberH74939134254010
Device Catalogue Number39134-25401
Device Lot Number18293088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age49 YR
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