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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939186202210
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/25/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the infrapopliteal artery.After a 0.14 guide wire crossed the lesion, a 2.0mm x 220mm x 150cm, coyote¿ balloon catheter was advanced on the popliteal artery.The 0.14 guide wire was removed and was exchanged with a victory 14 wire for more support.When the victory 14 was introduced into the lumen of the coyote¿ balloon catheter, the wire failed to track.Both devices were removed.Outside the patient's body, the physician tried to advance the guide wire into balloon.However, it was noted that the catheter was broken and instead of the wire following the lumen and came out the tip, the wire was inserted into the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a coyote balloon catheter.The balloon was loosely folded.The shaft is intact; there is no shaft separation.The balloon, markerbands, proximal bond and tip were microscopically examined.There was tip damage.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.There were numerous shaft kinks.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the infrapopliteal artery.After a 0.14 guide wire crossed the lesion, a 2.0mm x 220mm x 150cm, coyote¿ balloon catheter was advanced on the popliteal artery.The 0.14 guide wire was removed and was exchanged with a victory 14 wire for more support.When the victory 14 was introduced into the lumen of the coyote¿ balloon catheter, the wire failed to track.Both devices were removed.Outside the patient's body, the physician tried to advance the guide wire into balloon.However, it was noted that the catheter was broken and instead of the wire following the lumen and came out the tip, the wire was inserted into the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
COYOTE¿
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6771269
MDR Text Key81952614
Report Number2134265-2017-08014
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Model NumberH74939186202210
Device Catalogue Number39186-20221
Device Lot Number20445138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/25/2017
Initial Date FDA Received08/07/2017
Supplement Dates Manufacturer Received08/14/2017
Supplement Dates FDA Received08/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2017
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 Age58 YR
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