MAUDE Adverse Event Report: IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	7880
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event - event date was not reported and was approximated to (b)(6) 2021.
Event or Problem 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 or Problem 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.
Additional 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.

• Brand Name: IMPULSE GUIDE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11575162
• Report Number: 2134265-2021-03919
• Device Sequence Number: 3544352
• Product Code: DQO
• UDI-Device Identifier: 08714729153153
• UDI-Public: 08714729153153
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K120495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: 7880
• Device Catalogue Number: 7880
• Device Lot Number: 0060266237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1