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

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 07/12/2023

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: 510(k) no:k033583, k033913.1.Visual inspection of the actual sample: - the distal end had been fractured.- the outer layer of the actual sample was missing by approximately 3 mm in comparison with a current product sample.The fragment of the outer layer was not returned.2.Magnifying inspection of the actual sample: - the outer layer at the distal end had been cut, the gold coil was unraveled and exposed, and the core wire was exposed.- there were abrasions on the circumferential half of the guidewire in the area from the distal end to approximately 40 mm from the distal end.From this, it was presumed that the coating defect pointed out in this complaint referred to the above cut outer layer and the abrasions on the surface.- there was no anomaly such as abrasions or peeling of outer layer in other parts.3.Electron microscopic inspection of the actual sample: - the abrasions on the surface had been caused from the proximal side toward the distal side.From this, it was inferred that the actual sample was subjected to abrasion force in the distal direction while the part approximately 40 mm from the distal end was in contact with a hard object.- the end of the outer layer had been torn-off and wrinkles were observed in the vicinity of it.From this, it was inferred that tensile force and compressive force due to reaction at the time of cutting were applied to this part.- the distal end of the exposed gold coil was tapered and had a smooth surface.The same characteristics were observed on a current product sample.The core wire had a trace of fixed cut mark on the top surface.The same characteristics were observed on a current product sample.From this, it was presumed that no portion was missing from the gold coil and core wire.4.Outer diameter of the actual sample: - it met the factory's specifications.No anomaly was observed.5.History investigation of the involved product code/lot number: - no anomaly was found in the manufacturing records and shipping inspection record.- there has been no similar event reported from other facilities.[cause of occurrence/conclusion] based on the investigation result, as a possible cause of this case, the following mechanism was inferred.However, since the details of the occurrence situation were unknown, it was not possible to clarify the timing of occurrence.(1) some kind of hard object strongly came into contact with about 40 mm from the distal end of the actual sample.(2) in the state of (1), the actual sample was pulled in the proximal direction and exposed to abrasion force, which resulted in the abrasions on the surface.(3) when the pulling operation continued, the part approx.3 mm from the distal end of the actual sample was caught in some hard object, and when the pulling operation continued further, the outer layer was cut.Relevant instructions for use (ifu) reference: 'if any resistance is felt while removing the guide wire, do not remove the guide wire by force.Carefully remove the guide wire together with the catheter." 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 progreat had defective coating.The coating was "not finished".The progreat (and wire) was shaped before the procedure, therefore manipulated before insertion in the patient.He can't confirm if that was the cause or manipulation inside the patient.The procedure was completed successfully and there was not harm to the patient.

• Brand Name: TERUMO 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 ; 6402040886
• MDR Report Key: 17655111
• MDR Text Key: 322530005
• Report Number: 9681834-2023-00172
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 08/30/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MC-PP24131ZB
• Device Lot Number: 230201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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: COBRA 4F