• 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 Problems Shaft; Break
Event Date 05/08/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr: returned product consisted of a coyote es balloon catheter in two pieces. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube is completely separated 87. 7cm from the hub. The fracture faces were oval as if kinked prior to separation. The damage is consistent with damage seen with the use of a sheath. There is shaft damage at the exit notch that is consistent with damage seen with the use of a guide wire. There are numerous hypotube and shaft kinks. The tip is damaged. 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 shaft break occurred. Vascular access was obtained utilizing ipsilateral antegrade approach with a 4. 5fr non-bsc introducer sheath via left femoral artery. The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified peroneal artery and posterior tibial artery. A non-bsc guide wire was advanced and crossed the lesion. After a non-bsc balloon catheter was inserted, the physician attempted to perform kissing balloon technique and a 2mm x 40mm x 145cm coyote¿ es balloon catheter was advanced into the same sheath. However, it was noted that the coyote balloon catheter got stuck in the sheath and it could not be removed. The catheter balloon was pulled to be removed from the sheath but the shaft got detached. The device was completely removed and the procedure was completed with a non-bsc balloon catheter. No patient complications nor injuries were reported.

 
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 Key7571132
Report Number2134265-2018-04760
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 05/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939135204010
Device Catalogue Number39135-20401
Device LOT Number0021169895
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/14/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/23/2017
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: 06/05/2018 Patient Sequence Number: 1
Treatment
BALLOON CATHETER: IKAZUCHI PAD
GUIDEWIRE: CRUISE ETC
INTRODUCER SHEATH: PARENT 4.5FR
-
-