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

Model Number N/A

Device Problem Peeled/Delaminated (1454)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

The user facility reported that the progreat was removed from the packaging, the wire was unraveled and therefore no longer usable.Reported product was not used on patient.New progreat was used without any problems.The procedure outcome was not reported.No patient involved.

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.E2: health professional: unknown.E3: occupation: others.G4: 510(k) no:k033583, k033913.1.Inspection of the actual sample: 1.1 visual inspection found that the distal end of the actual catheter sample had been broken off and the reinforcement coil had been unraveled and exposed.1.2 magnifying inspection found that the actual guidewire sample had no anomaly in the appearance such as peeling of outer layer.1.3 from 1.2 and 1.2 above, it was inferred that the peeling of coating indicated in this complaint referred to the broken distal end of the catheter.[inspection of the actual catheter sample].1.4 magnifying inspection found that the inner layer was approximately 2.0 mm defective, and the outer layer was approximately 2.5 mm defective in comparison with a current product sample.The defective length of reinforcement coil was unknown because it was unraveled.1.5 magnifying inspection found that the area near the broken part had been crushed.The distal end of the unraveled reinforcement coil had been broken off.1.6 electron microscopic inspection found that the edge of outer and inner layers had been torn off.From this, it was inferred that some external force was applied to this area, which resulted in the breakage.[function confirmation].1.7 outer diameter of the actual catheter sample (normal section) met the factory's specifications.No anomaly was found.2.History investigation: 2.1 the manufacturing record and the shipping inspection record of the involved product code/lot#: no anomaly was found 2.2 past complaint file of the product with the involved product code/lot#: no other similar report from other facilities was found.3.Cause of occurrence: based on the results of the investigation, it was considered that the breakage was caused by some external force applied to the part in question; however, the timing could not be clarified because the details of the occurrence situation were unknown.The crush in the vicinity of the broken area was thought to be caused by the application of compressive force to the area, however, the timing could not be clarified.In the manufacturing process, the product undergoes 100% visual inspection under magnification after tip processing and before product packaging to confirm that there are no anomalies in the tip processing state; therefore, the detection of breakage or crushing at the same level as the actual catheter sample is probable enough.In addition, any breakage like that on the actual catheter sample have never been observed within the manufacturing process to date.Therefore, it was considered extremely unlikely that this event had occurred in the manufacturing process.Relevant instructions for use (ifu) reference.(cautions for use) precautions.Do not use if the unit packaging or the product have been damaged or soiled.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• 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: 17936407
• MDR Text Key: 326243915
• Report Number: 9681834-2023-00199
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/13/2023

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-PP27131
• Device Lot Number: 221109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• 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