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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 7880
Device Problems Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event - event date was not reported and was approximated to (b)(6) 2021.
 
Event Description
It was reported that there was a hole in the catheter.A 5f impulse guide catheter with a pigtail curve was selected for use in a coronary angiography procedure.During the procedure inside the patient, the catheter kinked.This resulted in an extra hole in the catheter, which the guide wire went through repeatedly.Another of the same device was used to complete the procedure.No patient complications were reported.
 
Event Description
It was reported that there was a hole in the catheter.A 5f impulse guide catheter with a pigtail curve was selected for use in a coronary angiography procedure.During the procedure inside the patient, the catheter kinked.This resulted in an extra hole in the catheter, which the guide wire went through repeatedly.Another of the same device was used to complete the procedure.No patient complications were reported.It was further reported that the kink occurred in the pigtail curve.The carrier tube was hydrated prior to removing the device from the tube.A number of minutes elapsed between the hydration of the carrier tube and the removal of the device from the tube.
 
Manufacturer Narrative
B3: date of event - event date was not reported and was approximated to (b)(6) 2021.Device evaluated by mfr: returned product consisted of a 5f impulse diagnostic catheter.The device was bloody.Analysis of the tip and shaft included microscopic and visual inspection.Inspection revealed a kink in the shaft located 8cm from the tip, and a hole was located at the site of the kink.The hole was pushed outward, indicating that something from the inside of the shaft perforated the shaft wall.Inspection of the rest of the device found no other damage or defect.
 
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Brand Name
IMPULSE GUIDE CATHETER
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key11575162
MDR Text Key242441857
Report Number2134265-2021-03919
Device Sequence Number1
Product Code DQO
UDI-Device Identifier08714729153153
UDI-Public08714729153153
Combination Product (y/n)N
PMA/PMN Number
K120495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/28/2022
Device Model Number7880
Device Catalogue Number7880
Device Lot Number0060266237
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2021
Date Manufacturer Received04/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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