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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COYOTE PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - MAPLE GROVE COYOTE PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number UNK719
Device Problem Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4). It is indicated that the device will not be returned for evaluation. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported that the shaft coating peeled off. The 99% target lesion was located in the moderately tortuous and severely calcified cephalic vein. A coyote balloon catheter was advanced to dilate the lesion. However, the device was unable to cross the lesion and it was also noted that the coating got peeled off. The procedure was completed with a non-bsc device. No patient complications nor injuries were reported.
 
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Brand NameCOYOTE PTA BALLOON DILATATION CATHETER
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 Key6902911
MDR Text Key87861527
Report Number2134265-2017-09610
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
Type of Report Initial
Report Date 09/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK719
Device Lot NumberBATCH_UNKNOWN
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 Received09/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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