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

Model Number	NC18131
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a right lower limb angiography for superficial femoral artery chronic total occlusion, access was obtained via the left common femoral artery using a six french cook ansel sheath.A 90-centimeter quick-cross catheter and a 260-centimeter angled glidewire were used to cross the chronic total occlusion, but the attempt was unsuccessful.Subsequently, access was obtained via the right anterior tibial artery using an 0.018-inch, 300-centimeter track wire and a 0.018-inch, 135-centimeter navicross catheter.The navicross catheter was advanced through the anterior tibial artery, popliteal artery, and into the chronic total occlusion cap.The track wire and navicross catheter were advanced into the six french ansel sheath.The wire was flossed through the sheath, with the track wire extending through the system.The physician attempted to withdraw the navicross catheter via the pedal access.During removal, the navicross catheter did not advance out as expected.One physician held the wire at the groin sheath, while a fellow managed the pedal wire, and another physician attempted to pull the navicross catheter.During this process, the catheter separated.The broken portion was removed, but another segment remained attached to the track wire.The track wire was cut to facilitate removal of the remaining catheter segment.The broken navicross catheter and the segment attached to the wire were retained.The distal end of the track wire was discarded.All components of the navicross catheter and track wire were successfully removed from the patient.A sheath was placed in the pedal access.A quick-cross catheter was used from the groin to access the tibial artery.A spartacore wire was advanced down the leg, and a hawk device was used for atherectomy.After several passes with the hawk device, the patient developed tachycardia and hypotension.Angiographic imaging revealed extravasation in the iliac artery and aorta.A coda balloon was deployed, and aortic/iliac stents were placed.Despite these interventions, the patient expired.The procedure performed was a left leg angiography.The event occurred intra-operatively.The estimated blood loss was less than 250 ccs.Additional information was received on 14 jul 2025: the sample showed blood and fluid contamination but no presence of anti-cancer agents.A physician involved in the case stated that there was no indication that terumo products caused or contributed to the patient's death.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: date of birth: requested, not provided.A4: weight: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.A historical investigation was conducted for the product associated with the specified product code and lot number.No anomalies were identified in the manufacturing or shipping inspection records.Additionally, no similar reports were found in the previous complaint files.Refer to section h10 for the importer's report and to the second report for details regarding the other device used during the reported even.Terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Additional Manufacturer Narrative
A4: weight: 53.8kg.This report is being sent as follow-up no.1 to update section a2, a4, b5, d9 and section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.The returned device included fragments of the navicross catheter that were stuck with the radifocus glidewire advantage track (hereinafter referred to as "actual device 1") and the main body of the navicross catheter (hereinafter referred to as "actual device 2").The fragment of actual device 1 measured approximately 375 millimeters, and actual device 2 measured approximately 990 millimeters, resulting in a total length of approximately 1365 millimeters.This length is approximately 15 millimeters longer than the current product specification, which has a shaft length of approximately 1350 millimeters.A flare was observed at the distal tip of actual device 1.Abrasion was noted near the fractured area of actual device 1, and tapering with abrasion was observed near the fractured area of actual device 2.These observations suggest that hard objects may have come into contact with the distal tip and the vicinity of the fractured areas.Additionally, the findings indicate that a tensile load may have been applied to the navicross catheter, resulting in fracture.Inside of the actual device 1 no anomaly was observed.The coil was elongated, and the length of the second marker was shorter than that of the current product.Coils were folded from the vicinity of the distal end of the second marker to the inside of the second marker, and elongation was also observed near the proximal end of the second marker.Coils were folded from the vicinity of the distal end of the third marker to the inside of the third marker, with additional elongation noted proximal to the third marker.These findings suggest that the coil was elongated or folded due to the application of pushing and tensile loads to the inner surface of the navicross catheter.Inside of the actual device 2 no coil elongation or folding was observed.The inner diameter at the hub side measured 0.54 millimeters and met factory specifications.No anomaly was found.The outer diameter of actual device 2 measured 0.84 millimeters and met factory specifications.No anomaly was found.The outer diameter of actual device 1 (fragment) ranged from 0.79 to 0.83 millimeters, which is approximately 0.05 millimeters thinner than that of actual device 2.These findings suggest that actual device 1 was elongated and thinned due to tensile load applied to the navicross catheter.Upon disassembly of actual device 1, the outer layer and reinforcement of the navicross catheter were removed to confirm the internal condition.It was found that the outer layer of the radifocus glidewire advantage track had a cut mark caused by a portion of the folded coils.No blood clots were observed.These findings suggest that the navicross coil became stuck by cutting into the outer layer of the radifocus glidewire advantage track.A historical investigation of the product code and lot number involved was conducted.No anomalies were found in the manufacturing record or the shipping inspection record.No similar issues were identified in past complaint files.The total length of the radifocus glidewire advantage track was approximately 2000 millimeters, which is approximately 1000 millimeters shorter than the current product specification of approximately 3000 millimeters.This cut is considered to have been made during the removal of the actual device in response to the reported complaint.One end of the radifocus glidewire advantage track was fractured diagonally, while the other end was processed to a rounded shape.These observations suggest that the diagonally fractured end corresponds to the cut made during removal of the actual device, as indicated in the complaint.Peeling of the polytetrafluoroethylene (ptfe) coating was observed near the area where the navicross catheter was stuck.This suggests that the ptfe coating was scraped by contact with another object.The outer diameter of the section without any visible anomaly measured 0.46 millimeters and met factory specifications.No anomaly was found.A historical investigation of the product code and lot number involved was conducted.No anomalies were found in the manufacturing record or the shipping inspection record.No similar issues were identified in past complaint files.A simulation test was conducted based on the consideration that tensile load may have been applied to the actual navicross catheter.In the test, the distal end of the current navicross catheter was trapped while the current radifocus glidewire advantage track was inserted, and tensile load was applied to the hub side.As a result, the shaft of the navicross catheter elongated by approximately 15 millimeters, and the outer diameter became thinner by up to 0.07 millimeters.Attempts to push and pull the radifocus glidewire advantage track under these conditions resulted in the navicross catheter becoming stuck with the radifocus glidewire advantage track.Elongation and folding were observed in the coil inside the navicross catheter.These conditions appeared to be similar to those observed in the actual device.Based on the investigation results, several factors were considered as potential causes of the reported issue; however, the exact details at the time of use were unknown and the root cause could not be definitively identified.The distal end of the navicross catheter appeared to have been trapped for an unknown reason while the radifocus glidewire advantage track was inserted.As tensile load was applied to the navicross catheter while the distal end was trapped, the shaft elongated and became thinner, resulting in a narrowed lumen.This caused resistance during operation of the radifocus glidewire advantage track.When the radifocus glidewire advantage track was pushed and pulled under these conditions, it came into strong contact with the inner surface of the navicross catheter.The coils were displaced and folded, cutting into the surface of the radifocus glidewire advantage track and becoming completely stuck.A tensile load was then applied while in the fully stuck state, resulting in fracture.Ashitaka factory is committed to maintaining product quality through the implementation of specific control measures.For the navicross catheter, a core wire equivalent to the inner diameter is inserted during the assembly process to confirm proper insertion.Sliding resistance of the inner surface is measured on a sampling basis to ensure there are no anomalies.A 100% visual inspection is performed to confirm the absence of kinks, crushes, or twists.For the radifocus glidewire advantage track, the outer diameter is measured to verify compliance with specifications.Prior to packaging, a 100% visual inspection is conducted to ensure there is no exposed core wire.The instructions for use (ifu) of this product indicates as follows: navicross: directions for use / 3./ cautions.Do not advance the guide wire briskly and/or force it into the catheter when the catheter is bent or twisted.This may cause breakage/separation of the catheter, resulting in damage to the vessel.Directions for use / 5./ cautions remove the product, the guide wire and the guiding catheter or sheath together if any resistance is felt while withdrawing the product.Radifocus glidewire advantage track: warnings, if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire advantage or failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel.
Event or Problem Description
Additional information was received on 04 aug 2025: upon inspection of the actual sample, it was observed that the 018300cm track may also be a contributing factor.Additional information was received on 07 aug 2025: the product in question was identified as the gat1830 guidewire advantage track 018 300cm.It was confirmed that the wire is not contaminated with any anticancer drug.Additionally, the assisting provider indicated that they did not believe the product was the cause of the issue.

• Brand Name: NAVICROSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 22768319
• Report Number: 9681834-2025-00143
• Device Sequence Number: 18494590
• Product Code: DQY
• UDI-Device Identifier: 04987892077272
• UDI-Public: (01)04987892077272(17)280229(10)250307
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2025

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: NC18131
• Device Catalogue Number: PN*NA180N3H
• Device Lot Number: 250307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/10/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F COOK ANSEL SHEATH.; 90CM QUICKCROSS WITH A 260CM ANGLE GLIDEWIRE.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White