MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/29/2023

Event Type  Injury  

Event Description

Terumo medical received an fda medwatch report # mw (b)(4).The event description states that during an aortogram with left leg angiogram a 4fr angled glide catheter broke, leaving a large remanent in the patient.The catheter was appropriately flushed pre-op during procedure set up and no damage was noted.When the md advanced the glidewire advantage through the catheter, he felt a snap and tried to pull the catheter out, that's when he noticed the catheter had broken off.An aortogram was performed, and a remanent piece of the catheter was able to be snared out.The catheter and remaining remanent were placed in biohazard bag and given to assistant manager as this appears to be a manufacturer issue.The original intended procedure was an ultrasound-guided access of bilateral common femoral arteries, nonselective catheter placement aorta times two.Stenting of bilateral common iliac arteries using an 8 x 37 visi pro stent on the left and an 8 x 27 visi pro stent on the right was performed.Percutaneous closure of bilateral common femoral arteries using two, 6 french angio-seals was done.The device did not function as intended.(e.G., broke, could not get it to work or stopped working).Additional information was received on 01nov2023: the patient was stable, and the procedure was able to be completed.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18182001
• MDR Text Key: 328741690
• Report Number: 2243441-2023-00043
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CG415
• Device Lot Number: 230322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2023
• Distributor Facility Aware Date: 10/30/2023
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 6 FRENCH ANGIO-SEALS; 8 X 27 VISI PRO STENT; 8 X 37 VISI PRO STENT
• Patient Outcome(s): Required Intervention; Other