MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION NAVICROSS 0.018"; CATHETER, PERCUTANEOUS

Model Number	NC18151
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: inventory specialist.The complaint was reassessed and deemed reportable based upon the investigation of the actual sample.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found.Visual and microscope inspections of the actual sample obtained the following results.The coil marker had been protruded from the distal end.The distal end of coil had been torn.The distal end of catheter collided with some object and fell inward.Longitudinal abrasion was found on the side of catheter.No tear was found in the distal end of coil of the product with the involved product code.X-ray fluoroscopic inspection of the inside of actual sample obtained the following results.The coil marker was unraveled to the center, and the section where winding wire density for a coil was high (marker part) could not be confirmed.The inner layer was not peeled off over the entire length.Confirmation of the inside of actual sample after disassembly obtained blood clots found inside the catheter.Therefore, it was inferred that although it was described in event information that "out of the package the navicross appeared to be frayed", the actual sample had been used.Simulation test: [test method] - pulling force was applied to the coil in a looped state and made it to fracture.[test result] - the distal end of coil was torn.This condition was likely to be similar to that of the actual sample.Since the fractured piece of coil was not returned, it is possible that it remains in the patient's body.Based on the investigation result, it was likely that the actual sample had been used, and the coil was fractured.The coil was likely to have fractured due to the following mechanism.However, since the details of procedure were unknown, the cause of occurrence could not be clarified.The inner layer was scratched due to some factor (e.G., abrasion by blood clots).Subsequent device operation pulled the coil toward the distal direction, causing it to unravel.Since external force was applied to the coil, it was fractured.Instructions for use (ifu) of this product includes the following warning and directions for use: "[warnings and precaution] warning: carefully handle the product under fluoroscopy.If any resistance is felt while handling the product, immediately stop the manipulation and find out the cause to avoid damage to blood vessels and separation or breakage of the product." "[directions for use] 3.Advance the guide wire and the product to the target vessel under fluoroscopy." 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 or Problem Description
The user facility reported that out of the package, the navicross appeared to be frayed.The product did not encounter the patient.The case was a peripheral superficial femoral artery (sfa) intervention.A new navicross was used.No patient injury was reported.The type of procedure performed was a peripheral intervention.The estimated blood loss was none.No equipment or other devices were used with the product involved.The patient was not injured, medical or surgical intervention was not required.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction to section d4: udi, d4: catalog number, and d4: model number.

• Brand Name: NAVICROSS 0.018"
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 18194291
• Report Number: 9681834-2023-00246
• Device Sequence Number: 17752236
• Product Code: DQY
• UDI-Device Identifier: 04987892077319
• UDI-Public: (01)04987892077319(17)260531(10)230613
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: NC18151
• Device Catalogue Number: PN*NA18153H
• Device Lot Number: 230613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown