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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 H74939185251210
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complaint device was not returned for 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 reported that balloon detachment occurred. Vascular access was obtained via the right femoral artery utilizing anterograde approach. The diffuse target lesion was located in the right peripheral leg artery. The physician was unable to cross the entire length of the lesion from the anterograde approach. A 4fr 10 cm sheath was engaged and crossed the right distal popliteal artery. Atherectomy was performed through the segment utilizing a non- bsc device. A 2. 5mm x 120mm x 150cm coyote¿ was selected to dilate the lesion. During preparation of the balloon, it was noted that the balloon peeled away from the balloon catheter while removing the stylet. The device was not used inside the patient and the procedure was completed with another 2. 5mmx120mmx150cm coyote balloon catheter. There were no patient complications reported.
 
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Brand NameCOYOTE¿
Type of DeviceCATHETER, 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 Key6584411
MDR Text Key75816456
Report Number2134265-2017-05070
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Model NumberH74939185251210
Device Catalogue Number39185-25121
Device Lot Number18289822
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

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