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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 H74939135404010
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that catheter entrapment occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified popliteal artery.After a non bsc guide wire crossed the lesion, a 4 mm x 40 mm x 146 cm coyote¿ es balloon catheter was advanced for dilatation.However the device was stuck when tried to pass through outside the patient's body.Upon removal, the non bsc guide wire separated.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that the 4mm x 40mm x 146cm coyote¿ es balloon catheter was the device that separated and not the non bsc guide wire as what was previously reported.The device was simply removed as the separation occurred outside the patient's body.
 
Manufacturer Narrative
Device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the returned product consisted of the coyote es balloon catheter in two pieces with a.014¿ guidewire.The guidewire was received in the distal end of shaft of the catheter.The shafts and balloon were microscopically examined.There were numerous kinks in the hypotube.The mid-shaft was stretched and completely separated.The separated ends of the midshaft appeared to be jagged and damaged.The exit notch was torn and the shaft was stretched and buckled distal of the exit notch.The outer shaft was buckled from the bi-component weld to the balloon and the inner shaft was buckled from the bi-component weld to the tip.The balloon was all bunched up and the tip was damaged.The appearance of the shaft indicates that the separation and buckling were due to tensile overload.An attempt to remove the guidewire was made; however, due to the buckling of the shaft and tip damage, the wire was unable to be removed.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 considered handling damage as the event occurred without direct patient contact.(b)(4).
 
Event Description
It was further reported that the 4mm x 40mm x 146cm coyote¿ es balloon catheter was the device that separated and not the non bsc guide wire as what was previously reported.The device was simply removed as the separation occurred outside the patient's body.
 
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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
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6552588
MDR Text Key74682303
Report Number2134265-2017-04504
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,distri
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/19/2017
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 Date04/30/2019
Device Model NumberH74939135404010
Device Catalogue Number39135-40401
Device Lot Number0019165463
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/19/2017
Initial Date FDA Received05/08/2017
Supplement Dates Manufacturer ReceivedNot provided
06/20/2017
Supplement Dates FDA Received06/19/2017
07/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2016
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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