MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA PROGREAT CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(4).The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Please see mdr 2243441-2019-00077 for the importer report.(b)(4).

Event Description

The user facility reported that the radifocus catheter broke apart in the external carotid artery.The patient's condition was reported to be fine.The procedure was successful.Additional information was received on 05aug2019.The procedure was a visceral procedure.The broken piece was retrieved from the patient.The patient's condition was stable.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection revealed that the outer layer of 0mm - approximately 8mm from the distal end had slipped proximally exposing the inner layer and the reinforcement.The outer layer on approximately 28mm - 32mm had buckled.There was no fracture observed over the entire length.The actual sample was inspected under magnification and electron microscope.The positional relationship between the distal tip of the inner layer and the radiopaque marker was found to accord with that between the distal end of the outer layer and the dent in which the radiopaque marker had been located.This infers that there was no missing part in the outer layer, in the reinforcement or in the inner layer.On the outer layer, a tear was found near the dent where the radiopaque marker had located.On the inner layer, no tear was found near the radiopaque marker.The coil pitch of the reinforcement had been disordered on 0mm-55mm from the distal end.Magnifying inspection of the lumen at the distal and the proximal end of the catheter tube did not find any blockage.The outer diameter was measured on the distal segment other than segment where the outer layer had been slipped or buckled and confirmed to meet the specifications.The inner diameter was measured on the proximal end of the catheter tube and confirmed to be comparable to that of a current product sample of the involved product code.Reproductive testing was performed.A factory-retained 2.8 f progreat catheter was prepared.The catheter and a guide wire were soaked with high-viscosity fluid and then combined in a manner that both can be stuck to each other.The guide wire in that state was exposed to repetitive push and pull manipulation in the catheter.As a result, the coil pitch of the reinforcement on the distal segment became disordered and gap was generated between the outer layer and the inner layer of the catheter.Subsequently, the catheter in that state was exposed to abrading force on the distal end.As a result, the outer layer of the catheter slipped proximally and buckled.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the involved guide wire became stuck in the distal segment of the actual sample due to some factors and was then exposed to pulling and pushing manipulation; due to this manipulation, the coil pitch of the reinforcement become disordered and gap was generated between the outer and inner layers.Subsequently, when the actual sample in that state was exposed to abrading force on the distal segment by coming into contact with some object, the outer layer slipped proximally and buckled with the generation of the tear.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: PROGREAT CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 8931083
• MDR Text Key: 155530832
• Report Number: 9681834-2019-00154
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350771810
• UDI-Public: 04987350771810
• Combination Product (y/n): N
• PMA/PMN Number: K033913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: MC*PE28131YB
• Device Lot Number: 190422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention