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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during an attempt to stent a renal artery after an endograft migrated up and covered the artery.The navicross tip broke off in the renal artery.It was stented over, and the procedure completed.There was no patient injury, medical/surgical intervention required.The patient's condition was stable.Additional information was received on (b)(6) 2021.Just the tip apparently broke off because they could only see one marker.A glidewire was used.Renal artery did not have calcification.It was difficult to get past the aaa graft.

• 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: 12066506
• Report Number: 2243441-2021-00027
• Device Sequence Number: 4111119
• Product Code: DQY
• UDI-Device Identifier: 04987350709189
• UDI-Public: 04987350709189
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/25/2021
• Report Date (Section F): 06/25/2021

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: NC35901
• Device Lot Number: 200907
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/11/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2021
• 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: 59 YR
• Patient Weight: 83
• Date Report Sent to FDA: 06/25/2021