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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 H74939185252210
Device Problems Bent (1059); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/29/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Device evaluated by mfr. : returned product consisted of the coyote balloon catheter. The balloon and tip were microscopically examined. There was contrast in the inflation lumen and balloon. The balloon was loosely folded. There were numerous kinks throughout the shaft of the device. Microscopic examination of the device revealed that the tip was damaged. The inner shaft was buckled at the distal markerband. There was a hole in the shaft with damage at the location of the hole. The shaft hole and damage is consistent with damage that can occur due to interaction with a guidewire. Inspection of the remainder of the device 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 cause of the reported difficulties may be due interaction with another device. (b)(4).

 
Event Description

Reportable based on device analysis completed on 10-may-2017. It was reported that tip damage occurred. The 95% stenosed, concentric, de novo target lesion was located in the severely tortuous and severely calcified proximal fibular artery. A 2. 5mmx220mm x150cm coyote¿ balloon catheter was advanced for pre-dilatation. However, upon entering the lesion, it was noted that approximately 0. 5mm of the distal tip of the catheter was folded. The device was completely removed from the patient's body and the procedure was completed with another balloon catheter. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed shaft detachment/separation.

 
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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 Key6583639
MDR Text Key75723323
Report Number2134265-2017-05178
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/10/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2020
Device MODEL NumberH74939185252210
Device Catalogue Number39185-25221
Device LOT Number20144669
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/17/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/13/2017
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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