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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 H74939135152010
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2018
Event Type  Injury  
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 obtained, a supplemental medwatch will be filed.   (b)(4).
 
Event Description
It was reported that shaft break occurred. The 100% stenosed target lesion was located in a severely tortuous and severely calcified right, below the knee vessel. After the guide wire was advanced, a 1. 5mm x 20mm x 143cm coyote¿ es balloon catheter was used several times and then advanced in the peripheral for plain old balloon angioplasty. The balloon was inflated six times for 30 seconds at 14 atmospheres. Upon withdrawal from the sheath, resistance was felt and the balloon got detached at the monorail part. The detached balloon was removed using a 4mm snare and the procedure was completed with a different device. No patient complications were reported.
 
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Brand NameCOYOTE¿ ES
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 Key7314101
MDR Text Key101525635
Report Number2134265-2018-01431
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
Type of Report Initial
Report Date 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/03/2020
Device Model NumberH74939135152010
Device Catalogue Number39135-15201
Device Lot Number21216088
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 Received02/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/05/2018 Patient Sequence Number: 1
Treatment
AMPLATZ GOOSENECK® SNARE KIT 4MM; GRADIUS GUIDEWIRE
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