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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

D4: udi: n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.G4: pma/510(k): k033583, k033913.The actual device has been returned for evaluation.The actual sample was the coaxial type, and the guidewire was stuck in the catheter.Visual inspection found breakage of catheter tube in the area approximately 1220 mm - 1320 mm from the distal end.Magnifying inspection of the broken area of the catheter found as follows: (i) ruptured outer layer and inner layer; (ii) wrinkling of the inner layer on the distal side (iii) wrinkling of the catheter tube on the proximal side; (iv) stretched and fractured coil reinforcement; (v) separated pieces of outer layer and inner layer at approximately 1260 mm from the distal end.Magnifying inspection of the catheter found wrinkling at approximately 1330 mm, 1350 mm, and 1440 mm from the distal end.Magnifying inspection found no crush, wrinkling, or other anomaly in the other areas of the catheter.Magnifying inspection of the guidewire found no anomaly in the condition of outer surface.Function confirmation of the outer diameter of catheter (undamaged section) met the factory's specification.No anomaly was found.Inner diameter of catheter (undamaged section) met the factory's specification.No anomaly was found.Outer diameter of guidewire met the factory's specifications.No anomaly was found.History investigation of the involved product code/lot # found no anomaly in the manufacturing record and the shipping inspection record.No other similar case was reported from other facilities.Simulation test was conducted.A simulation test was conducted with a factory retained progreat to reproduce the condition of the actual sample.An attempt was made to remove the preloaded guidewire from the progreat in an insufficient primed state.As a result, the sliding property of both devices was deteriorated leading to sticking state.The proximal side of the catheter was grasped with one hand, the guidewire was grasped with the other hand, and an attempt to release the sticking state was made by applying pushing and pulling force to the guidewire.Visual and magnifying inspection of the tested sample found as follows: (i) ruptured outer layer and inner layer; (ii) wrinkling of the inner layer on the distal side; (iii) stretched and fractured coil reinforcement.The above-mentioned state was thought to be similar to the state of the actual sample.Cause of occurrence, as this product is subjected to 100% visual inspection in the manufacturing process, any breakage of the same level as this case can be detected at this inspection stage.Therefore, in this case, it was thought that the breakage may have occurred by an application of external force like that reproduced in the simulation test to the relevant area at the time of removal of the devices or afterward.However, as the details on the occurrence situation were unknown, the cause could not be clarified.Relevant instructions for use (ifu) reference: make sure that the lock adapter is not loose.Inject heparinized saline solution into the guide wire hub using the attached 2.5 ml luer lock syringe.In order to prime the catheter sufficiently, slowly inject at least 1 ml of the solution into the catheter until more than 10 drops of the solution appear out of its tip.To maintain surface lubricity, immerse the catheter and the guide wire assembly in a heparinized saline solution bath or put it into its holder filled with heparinized saline solution.Prime the catheter and guide wire sufficiently.Manipulation of an insufficiently primed catheter may cause wrinking, separation of the catheter, and/or abrasion of the hydrophilic coating on the guide wire.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that the when the doctor took out the involved product, he immediately found that the progreat's body had broken skin.The catheter was broken when taken out.The physician found the defect when he took out microcatheter from the holder at the first time, before entering human body and changed to a new one.No patient involvement.The event occurred pre-treatment.

• Brand Name: PROGREAT CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18461285
• MDR Text Key: 332737083
• Report Number: 9681834-2023-00262
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MC-PP27131
• Device Lot Number: 230315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1