• 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¿ ES 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¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939135204010
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4).
 
Event Description
It was reported that balloon tear occurred. The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery (sfa). A 2mm x 40mm x 145cm coyote¿ es balloon catheter was advanced to dilate the lesion. After dilating the proximal part of sfa, the device was advanced to the distal part; however, it was noticed through fluoroscopy that the balloon part shifted from the wire. When the physician tried to pull it out, it was observed that it was torn from the tip to the middle part of the balloon. The device was completely removed from the patient and the procedure was completed with another 3. 0mm coyote¿ es balloon catheter. No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of a coyote es balloon catheter with an unidentified. 014 guidewire stuck in the guidewire lumen with the distal part of the guidewire protruding out of the distal shaft and balloon. The balloon was loosely folded with blood in the inflation lumen and balloon. The outer shaft, inner shaft, balloon and tip were microscopically examined. The tip is damaged. There is an inner shaft puncture hole 6mm from the proximal markerband where the guidewire is protruding through. The balloon has a 19mm longitudinal tear starting 5mm from the proximal markerband, where the guidewire is protruding through the shaft and balloon. The shaft puncture hole and balloon tear is consistent with damage seen with the use of a guidewire. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any material or manufacturing deficiencies contributing to the damage and the confirmed event. The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event. (b)(4).
 
Event Description
It was reported that balloon tear occurred. The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery (sfa). A 2mm x 40mm x 145cm coyote es balloon catheter was advanced to dilate the lesion. After dilating the proximal part of sfa, the device was advanced to the distal part; however, it was noticed through fluoroscopy that the balloon part shifted from the wire. When the physician tried to pull it out, it was observed that it was torn from the tip to the middle part of the balloon. The device was completely removed from the patient and the procedure was completed with another 3. 0mm coyote es balloon catheter. No patient complications were reported and the patient's status was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7582835
MDR Text Key110578179
Report Number2134265-2018-05047
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 05/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/04/2020
Device Model NumberH74939135204010
Device Catalogue Number39135-20401
Device Lot Number21475493
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-