MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION NAGARE BI-DIRECTIONAL 8.8FR; DEVICE, HEMOSTASIS, VASCULAR

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

Lot number: requested, unknown.Expiration date: unknown due to unknown catalog and lot combination.Udi: unknown due to unknown catalog and lot combination.Implanted date - device was not implanted.Explanted date - device was not explanted.Device manufacture date: unknown due to unknown catalog and lot combination.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.There is insufficient evidence to determine the root cause, no details were provided by the physician and the device was not returned.Due to the lack of evidence and information for investigation, no determination can be reliably made.The potential cause of leaking could be the misuse of the insertion tool during introduction or removal of the advisor hd mapping grid through the valve.There is no known compatibility issue found and no complaints have been recorded to indicate the nagare bi-directional steerable sheath s8fmb74 has compatibility issues with a device.Engineering did not find evidence for compatibility as a contributing factor.This report is for the second event reported, for the first event reported see mdr 3009149192-2021-00001.

Event Description

The user facility reported that the nagare sheath was used with an abbott device (mapping catheter and ablation catheter) and blood leakage occurred in three cases and blood leakage occurred in all cases.Since the leakage did not occur with the sheaths of other manufacturers, it might be a compatibility issue.There was no health damage to the patient.Additional information was received on 24november 2021: it was reported that an abbot product was used with this case however it was confirmed that the actual product in use was a nihon koden product.The blood loss amount was more than 250cc's in the second and third incidents, and less than 250cc in the first incident.There was a lot of blood in the first and second case and the sheath was replaced.The blood loss did not require a blood transfusion for the patient.The third patient has been confirmed to be in stable condition.

• Brand Name: NAGARE BI-DIRECTIONAL 8.8FR
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset NJ 08873
• Manufacturer (Section G): KALILA MEDICAL, INC.; 1400 dell ave ste c; campbell CA 95008 6620
• Manufacturer Contact: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13067384
• MDR Text Key: 282770292
• Report Number: 3009749192-2021-00002
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162427
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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: SS8FMB74
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (PRODUCT CODE: H101J/ NIHON KODEN); (PRODUCT CODE: H420E/ NIHON KODEN); ABLATION CATHETER: TACTICATH SE DD; MAPPING CATHETER: ADVISOR HD GRID; TACTICATH ABLATION CATHETER (ABBOTT)
• Patient Outcome(s): Other