• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939185402210
Device Problems Failure to Advance; Catheter
Event Date 02/06/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by mfr. : the complaint device was returned for analysis. Returned product consisted of a coyote balloon catheter. The balloon was loosely folded. There was contrast and blood in the inflation lumen. The outer shaft, inner shaft, balloon and tip were microscopically examined. There was tip damage. Functional testing using an inflation device to inflate the balloon to the rated burst pressure revealed a pinhole in the balloon material. There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty. Inspection of the remainder of the device presented no other damage or irregularities. 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

Reportable based on analysis completed on 29mar2017. It was reported that crossing difficulties were encountered. The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa). A 4. 0mm x 220mm x 150cm coyote¿ balloon catheter was advanced but failed to cross the lesion. The procedure was completed with a different device. No patient complications were reported. However, returned device analysis revealed a balloon pinhole.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6487883
Report Number2134265-2017-03551
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 03/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device MODEL NumberH74939185402210
Device Catalogue Number39185-40221
Device LOT Number18801984
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/08/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/15/2016
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: 04/12/2017 Patient Sequence Number: 1
Treatment
GUIDE WIRE: CRUISE GUIDE WIRE
-
-