MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA NAVICROSS; CATHETER, PERCUTANEOUS

Model Number	NC35131
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: sex: requested, not provided.A3b: gender: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: lot #: requested, unknown.D4: expiration date, udi: unknown, as the involved product lot # was unknown.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: vascular surgeon.H4: device manufacture date: unknown, as the involved product lot # was unknown.The actual sample has not been received by ashitaka factory yet.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Since the lot# was unknown, the manufacturing record, the shipping inspection record, and the past complaint file of the product with the product code/lot# involved could not be investigated.The manufacturing records for the past two years were investigated.No cases of markers falling off due to manufacturing defects were found.Since the lot# was unknown.For the importer report for this reported event please see mdr 2243441-2024-00024.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 the doctor performed an intervention and angioplasty on the distal superficial femoral artery (sfa), popliteal, and tibial arteries.There was a very tight lesion that presented difficulties in crossing, and she used the.035x135 angled navicross aggressively, along with various wires.The distal radiopaque marker of the navicross detached from the catheter and lodged in the distal anterior tibial artery.This did not obstruct blood flow, and the physician decided not to remove it.The procedure performed was a right leg peripheral arterial disease (pad) intervention, with no blood loss reported.The incident occurred intra-operative.The reported incident did not result in patient injury or medical or surgical intervention.
Additional Manufacturer Narrative
This report is sent as follow-up no.1 to correct section d9, update section h3, and to provide the completed investigation results.The actual device was returned for evaluation.The appearance of the actual sample revealed several observations.The second marker was missing, and a caulking mark was found at the second marker position.No anomalies, such as floating, were found in the third marker.Extensive abrasions in the distal direction were observed beyond the second marker's caulking mark, likely caused by the displacement of the second marker toward the distal direction.Additionally, abrasions in the distal direction were found at the proximal side beyond the second marker's caulking mark, inferred to have occurred when the actual sample was removed while in contact with some object.The dimensions of the actual sample were measured.The outer diameter of the shaft met the factory's specifications, with no anomalies found.The depth of caulking at the second marker, determined by the difference between the outer diameter of the caulking mark and the outer diameter in the vicinity of the caulking mark, was equivalent to that of the current product with the second marker removed.No anomalies were found.Cause of occurrence: no anomalies were found in the dimensions of the actual sample.Based on investigation result 2, the depth of caulking of the actual sample was equivalent to that of the current product, indicating that the second marker was likely properly caulked.The likely cause of this issue is that the actual sample was removed while in excessive contact with some object (e.G., a site of stenosis), resulting in abrasions in the distal direction at the proximal side beyond the second marker.Furthermore, the second marker came into excessive contact with the object, causing it to be dragged toward the distal direction and eventually fall off.Countermeasure: the use (ifu) reference of this product includes the following warning: - carefully handle the product under fluoroscopy.If any resistance is felt while handling the product, immediately stop the manipulation and identify the cause to avoid damage to blood vessels and prevent separation or breakage of the product.

• Brand Name: NAVICROSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, 418 ; JA 418
• 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: 20056137
• Report Number: 9681834-2024-00149
• Device Sequence Number: 20779433
• Product Code: DQY
• UDI-Device Identifier: 04987350709202
• UDI-Public: 04987350709202
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110540
• 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): 08/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NC35131
• Device Catalogue Number: WS*NA350N3H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown