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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 H74939135204010
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon rupture occurred.Vascular access was obtained from the same side of the lesion.The target lesion was located in the anterior tibial artery.After a non bsc guide wire crossed the lesion, a 2mm x 40mm x 145cm coyote es balloon catheter was advance.The balloon was inflated however it ruptured at 14 atmospheres on the first inflation.No segment of the balloon was detached inside the patient after it ruptured.The procedure was completed using a 2.0mm coyote balloon catheter.No patient complications were reported and the patient's status was good.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: returned product consisted of a coyote es balloon catheter.The balloon was loosely folded with blood in the balloon and in the air lumen.Functional testing was performed by attaching an inflation device filled with water to the device.When positive pressure was applied, a stream of water emitted from the balloon wall.The balloon was microscopically examined and there was a pinhole in the balloon wall 42mm from the tip of the device.Microscopic examination presented no irregularities in the balloon material or the ro marker that could have contributed to the damage.Microscopic examination presented no damage or irregularities to the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.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
It was reported that balloon rupture occurred.Vascular access was obtained from the same side of the lesion.The target lesion was located in the anterior tibial artery.After a non bsc guide wire crossed the lesion, a 2mm x 40mm x 145cm coyote es balloon catheter was advance.The balloon was inflated however it ruptured at 14 atmospheres on the first inflation.No segment of the balloon was detached inside the patient after it ruptured.The procedure was completed using a 2.0mm coyote balloon catheter.No patient complications were reported and the patient's status was good.
 
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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 Key5305882
MDR Text Key33733430
Report Number2134265-2015-08748
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K080982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/24/2017
Device Model NumberH74939135204010
Device Catalogue Number39135-20401
Device Lot Number16845015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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