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

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

A2: date of birth: requested, not available.A3b: gender: n/a.A4: weight: requested, not available.A5: ethnicity: requested, not available.A6: race: requested, not available.D4: udi: n/a at this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: telephone number: requested, not available.E2: health professional: unknown.E3: occupation: others.G4: pma/510(k): k033583.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.1.The manufacturing record and the shipping inspection record of the involved product code/lot# no anomaly was found.2.The past complaint file of the product of the involved product code/lot# no other similar report from other facilities was found.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that a 5f puncture sheath introduced via femoral artery puncture, rh hepatic duct to abdominal trunk, followed by microcatheter progreat superselected to the right hepatic artery, which was filled with embolised microspheres before microcatheter progreat was superselected to the right hepatic trunk and returned to the ward for perfusion chemotherapy; microcatheter delivery tube fracture on the latter day.There's no debris left in the patient.The procedure outcome was not reported.The patient was not harmed.Additional information was received on february 6, 2024: the procedure is haic, which need to keep the tube in the body about one to two days.The fracture happened after the procedure.After microcatheter delivery tube fracture on the next day, the operator performed an angiogram.

Manufacturer Narrative

This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device has been returned for evaluation.The actual sample and the angiographic catheter were received in the state where both devices were sticking to each other.1.Appearance confirmation: [visual inspection] 1.1 the catheter shaft had been broken at the vicinity of the strain relief and divided into two portions.[magnifying inspection] 1.2 only the outer layer had been broken off, and no elongation was found on the outer layer in the vicinity of both broken ends.1.3 the coil reinforcement had been exposed at the broken end of the distal portion.1.4 the inner layer was elongated and exposed from the broken end of the distal portion, and the end of coil reinforcement was confirmed on the inner layer 1.5 no abnormalities such as roughness was found on the top surface of the inner layer of the distal portion.[x-ray fluoroscopic inspection] 1.6 no inner layer and no coil reinforcement were left from the hub through the broken end of the proximal portion.(from 1.5 and 1.6, it was thought that the inner layer and the coil reinforcement were not broken off but had come off the outer layer of the proximal portion.) 1.7 the outer layer inside the strain relief was deformed.1.8 the coil reinforcement was elongated starting from approximately 15 mm from the broken end of outer layer of the distal portion.[electron microscopic inspection] 1.9 abrasions were observed on the outer layer surface near the broken end of the distal portion.1.10 roughness was observed on the outer layer surface at approximately 15 mm from the broken end of the distal portion.(from the investigation results 1.9 and 1.10, it was inferred that some hard object had come into contact with this area.) 2.Function confirmation: outer diameter of the catheter (undamaged section): it met the factory's specification.No anomaly was found.3.Simulation test: based on the investigation results 1.9 suggesting that some hard object had come into contact with the outer layer of the actual sample, a simulation test was performed as follows.A scratch was made intentionally to the outer layer of a factory-retained progreat.The progreat was grasped at the hub and the shaft, and then subjected to a pulling load.As a result, the outer layer broke off at the scratched position, which resulted in the exposure of coil reinforcement.When the progreat was subjected to further pulling force, the inner layer was elongated and exposed.No elongation was observed at the broken end of the outer layer.This state was thought to be similar to that of the actual sample.4.Cause of occurrence/conclusion: based on the investigation result, as a possible cause of this case, the following mechanism was inferred.(1) the actual sample was exposed to some hard object and abraded, leading to deterioration in the strength of outer layer.(2) when a pulling load was applied to the actual sample in the state of (1), the outer layer broke off starting from the abraded part.Relevant ifu reference: "if any resistance is felt, do not remove the micro catheter system by force.Withdraw the catheter carefully together with the guiding catheter.Removing the catheter by force may result in the catheter breakage/separation, which may necessitate retrieval." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: PROGREAT
• 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: 18842509
• MDR Text Key: 337806784
• Report Number: 9681834-2024-00025
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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-PC2413
• Device Lot Number: 230126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Male