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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.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 review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.Please see mdr 2243441-2021-00049 for the importer report.(b)(4).
Event or Problem Description
The user facility reported that the tip of the.018 navicross catheter broke off in the subintimal space.The patient was in stable condition and the procedure outcome was successful.Additional information was received on 27sept2021.The procedure was for peripheral arterial disease (pad) / chronic total occlusion (cto) in the superficial femoral artery (sfa).The piece was left behind in the subintimal space.Surgical intervention was not required.It appeared to be a piece of the radiopaque marker on the distal tip.018 navicross catheter.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection revealed no anomaly such as a kink or breakage.Magnifying inspection of the actual sample found no scratches or other anomalies in the appearance.The actual sample was inspected under x-ray fluoroscope.Approximately 250 mm from the distal end - the proximal end of the shaft, the coil marker was found unraveled and disturbed.The first, the second and the third radiopaque markers were missing.The coil marker had been folded back toward the proximal direction at approximately 250 mm from the distal end; therefore, two lines of coil marker were observed in the area from 250 mm to 800 mm from the distal end.One end of the coil marker was found located about 800 mm from the distal end.At the proximal end of the shaft, the coil marker was found to have folded again toward the distal direction; therefore, in the area approximately 800 mm from the distal end - the proximal end of the shaft, three lines of coil marker were observed.The actual sample was analyzed by ct.The lumen had been blocked by the unraveled coil marker.However, in the proximal section of the shaft, the lumen of about 0.46 mm in id was retained though the coil marker had overlapped triply.The outer and inner diameters of the actual sample were measured and confirmed to meet the control standards.Ifu states: warnings.Careful when exchanging a guide wire while leaving the product in the vessel.Carefully insert a guide wire into the product.If any resistance is felt, stop the manipulation and remove the product together with the guide wire to avoid separation or break of the product.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation result verified that the coil marker had been doubled in the wide range from the point at about 250 mm from the distal end to the proximal end of the shaft, and in the proximal section of the shaft, the lumen of about 0.46 mm in id was retained though the coil marker had overlapped triply.It was likely that the concurrently used guidewire might have been caught in the actual sample, and then the guidewire in that caught state might have been manipulated in the withdrawal direction.This might have caused the coil marker of the actual sample to be dragged in the proximal direction, unraveled, and disturbed.The breakage of the tip that was pointed out in this complaint was not confirmed during the investigation.As for the coil marker, they were in a state of disarray and unraveling, therefore, it was not possible to identify whether or not there was any missing portion.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: TERUMO NAVICROSS SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12642484
• Report Number: 9681834-2021-00179
• Device Sequence Number: 3421925
• Product Code: DQY
• UDI-Device Identifier: 04987892077234
• UDI-Public: 04987892077234
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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 Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: NC18901
• Device Lot Number: 210419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 78 KG