Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 H74939186150410
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/28/2017
Event Type  malfunction  
Manufacturer Narrative
Complainant name: (b)(6).(b)(4).Returned device consisted of a coyote balloon catheter and a guide wire.The balloon was loosely folded and the guide wire was loaded into the coyote device.The tip, hypotube, inner shaft and outer shaft were microscopically inspected.Inspection revealed inner shaft damage (buckling) for 41 mm located inside the balloon material, balloon damage (bunching) and tip damage (misshapen/bunched up).The inner diameter of the shaft could not be measured, as the guide wire could not be separated from the coyote.Microscopic inspection found the remainder of the device free of damage.Functional testing of the device could not be done, due to the condition of the returned device.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
 
Event Description
Same case as mdr# 2134265-2018-01393.Reportable based on analysis completed on 05-feb-2018.It was reported that the device was difficult to advance.The target lesion was located on the right side below the knee.A 1.5mmx40mmx150cm coyote¿ balloon catheter was introduced over a v-14¿ controlwire® through a 5f 45cm non-bsc introducer sheath.The balloon wasn't inflated in the sheath.The catheter and wire could not be advanced from the sheath and were both removed.The procedure was completed with another of the same device.No patient complications were reported and the patient is fine.However device analysis revealed catheter was froze on wire.
 
Manufacturer Narrative
Corrected: (b)(4).Corrected: device evaluated by mfr (below).Device evaluated by mfr originally reported as: returned device consisted of a coyote balloon catheter and a guide wire (related device, mdr# 2134265-2018-01393).The balloon was loosely folded and the guide wire was loaded into the coyote device.The tip, hypotube, inner shaft and outer shaft were microscopically inspected.Inspection revealed inner shaft damage (buckling) for 41 mm located inside the balloon material, balloon damage (bunching) and tip damage (misshapen/bunched up).The guide wire could not be separated from the coyote.Microscopic inspection found the remainder of the device free of damage.Functional testing of the device could not be done, due to the condition of the returned device.Additional investigation revealed the following; since the guidewire could not be removed from the coyote catheter, both devices were sent to another bsc investigation site for analysis of the guidewire.During the analysis, the wire was able to be removed from the balloon catheter.The coyote balloon catheter was sent back to maple grove for further analysis.Additional analysis of the coyote balloon catheter found the device was returned without the related guidewire and was reviewed again.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.The inner shaft is buckled in numerous locations under the balloon.The damage is consistent with the damage that is seen caused by use of a guidewire.Functional testing was completed using a thruway.014 guidewire.The thruway guidewire was inserted through the distal tip and could not advance due to the damage.(b)(4).
 
Event Description
Same case as mdr# 2134265-2018-01393.Reportable based on analysis completed on 05-feb-2018.It was reported that the device was difficult to advance.The target lesion was located on the right side below the knee.A 1.5mmx40mmx150cm coyote¿ balloon catheter was introduced over a v-14¿ controlwire® through a 5f 45cm non-bsc introducer sheath.The balloon wasn't inflated in the sheath.The catheter and wire could not be advanced from the sheath and were both removed.The procedure was completed with another of the same device.No patient complications were reported and the patient is fine.However device analysis revealed catheter was froze on wire.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COYOTE¿
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
MDR Report Key7303648
MDR Text Key101470940
Report Number2134265-2018-01392
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/02/2020
Device Model NumberH74939186150410
Device Catalogue Number39186-15041
Device Lot Number20595282
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2018
Date Manufacturer Received04/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
INTRODUCER SHEATH: 5F TERUMO 45CM
-
-