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	Death
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.

• 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
• MDR Report Key: 22768337
• Report Number: 2243441-2025-00041
• Device Sequence Number: 13158129
• 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
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2025
• Report Date (Section F): 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/11/2025
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 08/10/2025