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
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.

• 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
• MDR Report Key: 12642464
• Report Number: 2243441-2021-00049
• Device Sequence Number: 3313538
• Product Code: DQY
• UDI-Device Identifier: 04987892077234
• UDI-Public: 04987892077234
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2021
• Report Date (Section F): 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: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: NC18901
• Device Lot Number: 210419
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/20/2021
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Weight: 78
• Date Report Sent to FDA: 10/15/2021