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

Model Number	WS*NS350G3H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/22/2019
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 records and the shipping inspection record of the involved product/lot# combination was conducted with no findings.Please see mdr 9681834-2019-00126 for the manufacturer report.
Event or Problem Description
The user facility reported that the navicross catheter kept getting stuck in severe calcium in the hunter's canal.The catheter was being used in conjunction with a crosperio through pedal access.The balloon was inflated and the balloon had something constricting it in the middle portion.When the catheter was pulled back, it appeared that the outer coating was pulled off.The procedure was completed successfully.Additional information was received on june 28, 2019.The procedure was an endovascular revascularization sfa occlusion - cto; long segment occlusion.The tip of the navicross broke off at the first ring with the bright tip marker and was retrieved with a balloon.There was no piece left in the patient.The patient condition was reported to be fine after the procedure.There was blood loss in the amount of 50cc.

• 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: 8800514
• Report Number: 2243441-2019-00056
• Device Sequence Number: 262267
• Product Code: DQY
• UDI-Device Identifier: 04987350709240
• UDI-Public: 04987350709240
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2019
• Report Date (Section F): 07/17/2019

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: 12/31/2021
• Device Model Number: WS*NS350G3H
• Device Catalogue Number: NC35650
• Device Lot Number: 190122
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2019
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2019
• 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: Required Intervention
• Date Report Sent to FDA: 07/17/2019