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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 H74939135254010
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of the coyote es balloon catheter in two pieces. The shafts and balloon were microscopically examined. There was blood in the inflation lumen and balloon. The balloon was loosely folded. There were numerous kinks proximal of the exit notch and throughout the distal shaft. There was a shaft separation 1mm distal of the exit notch. The inner shaft was buckled 3mm distal of the bi-component weld and in the balloon 4mm proximal of the distal markerband. The tip was damaged. 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 detachment occurred. The target lesion was located in the severely calcified vessel below the knee. A 2. 5mm x 40mm x 146cm coyote¿ es balloon catheter was advanced to dilate the lesion. After several dilatations were performed, the device was attempted to be removed from the patient's body; however, the balloon got detached near the guidewire exit port. The detached balloon was then removed by snaring. The procedure was completed with a different device and vascular patency was observed. No patient complications were reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon detachment occurred. The target lesion was located in the severely calcified vessel below the knee. A 2. 5mm x 40mm x 146cm coyote¿ es balloon catheter was advanced to dilate the lesion. After several dilatations were performed, the device was attempted to be removed from the patient's body; however, the balloon got detached near the guidewire exit port. The detached balloon was then removed by snaring. The procedure was completed with a different device and vascular patency was observed. 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 Key6613123
MDR Text Key108307417
Report Number2134265-2017-05558
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,Followup
Report Date 05/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberH74939135254010
Device Catalogue Number39135-25401
Device Lot Number0020110206
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/28/2016
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: 06/05/2017 Patient Sequence Number: 1
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