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

Model Number N/A

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

D4: udi: n/a at this product code is not exported to the us market.G4: pma/510(k): k033913 the returned items were the actual progreat catheter (the actual sample), a guidewire, and an angiographic catheter.They were stuck to one another.[appearance confirmation]: visual inspection found that the guidewire was deformed.Visual inspection found damage to the actual sample.Magnifying inspection of the damaged part of the actual sample found that: the inner layer and the outer layer had been ruptured.The catheter had been wrinkled like an accordion.Coil reinforcement was exposed.Electron microscopic inspection of the actual sample found an abrasion from the distal end toward the proximal side.Electron microscopic inspection of the actual sample found a machining mark at the distal end of the coil marker.From this, no loss of coil marker was considered to have occurred.X-ray fluoroscopic inspection inside the angiographic catheter revealed no anomaly such as a separation of the actual sample or the clogging in the lumen of angiographic catheter.Magnifying inspection of the deformed part of the guidewire found peeling of coating.The distal part of the actual sample was disassembled, and the surface condition of the guidewire located inside was checked.Multiple adherent materials were observed on the surface.[component analysis]: the adherent material on the guidewire was subjected to ft-ir component analysis and confirmed to have spectrum similar to that of the coating of guidewire.From this, it was thought that the coating of the guidewire that had peeled from the deformed part migrated and adhered to the involved area.*ft-ir analysis (fourier transform infrared spectroscopy) is a method for analyzing the spectrum obtained by irradiating the measurement object with infrared rays.[function confirmation]: the outer diameter of the actual sample (undamaged part) met the factory's control standard.No anomaly was observed.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar event from other facilities was found in the past complaint file.[simulation test]: a simulation test was performed regarding this case using factory-retained samples.A guidewire was made stuck to the distal end of a progreat.The sticking catheter was subjected to pulling load.As a result, the catheter was elongated, and the outer layer and the inner layer were ruptured.After the rupture occurred, the catheter was subjected to pushing and pulling loads in order to release the sticking state, which resulted in accordion-like wrinkles, exposure of coil reinforcement, and rupture of outer and inner layers.This state was thought to be similar to that of the actual sample.From the investigation result, as a possible cause of this case, the following mechanism was inferred.The guidewire had been deformed and the coating had been peeled for some reason.When the actual sample was removed, the peeled guidewire coating was entered and adhered between the lumen of the actual sample and the guidewire, causing both devices to stick to each other.Attempt to remove the actual sample made the actual sample to be elongated and the outer and inner layers to be ruptured.The actual sample was subjected to pulling and pushing loads, leading to the accordion-like wrinkles.Relevant instructions for use (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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the procedure performed was a renal embolization and a progreat 2.4 french would not engage.The user tried to exchange for a different microcatheter over an 018 bosotn v18 wire; however, the wire became stuck and when tried to remove it the wire started to unravel.The wire was stuck in the catheter.It was all removed, and the procedure completed with a 2.7 french progreat.The v18 has started to unravel; however, it was still connected.The event occurred intra-operative.The was no harm to the patient.There was no patient injury/medical or surgical intervention required.

• 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: 18894621
• MDR Text Key: 337553477
• Report Number: 9681834-2024-00033
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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-PP24131ZD
• Device Lot Number: 230525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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
• Treatment: 018 BOSOTN V18 WIRE