MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 07/29/2023

Event Type  Injury  

Event Description

Terumo medical received a user facility medwatch report # (b)(4).The event description states: during deployment of angioseal arterial closure device the end of the device fractured inside the femoral artery.Fractured device has been sequestered in director's office and manufacturer representative has been contacted.Fractured piece of device was successfully removed from the patient.Surgical intervention required to retrieve fractured device end.Additional information was received on 01 sept 2023: the procedure was performed for repositioning of an impella device, right heart catheterization with swan-ganz catheterization through the left femoral vein, removal of the arterial sheath from the right femoral artery.A 7-french arterial sheath was used.There were no issues with access for any of the devices.Only upon removal was there difficulty and the breakage of the tip of the angio seal sheath.A judkins left catheter, 6-french 4.0 curved left coronary artery angiography was performed pre deployment.There was an estimated 500cc of blood loss.The patient was stabilized after being transferred to the operating room for bypass graft femoral artery, right groin exploration, control bleeding, and retention catheter.The patient was discharged safely on (b)(6) 2023.

Manufacturer Narrative

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 record of the product code/lot# combination was conducted with no findings.

Manufacturer Narrative

This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint was unable to be confirmed since the sample was not available for evaluation.The exact root cause cannot be determined.The likely cause was determined to have been damage sustained by the device due to aggressive use or excessive force.The device history record (dhr) review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing, design, or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).

• Brand Name: 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset NJ 00873
• Manufacturer (Section G): TERUMO PUERTO RICO LLC; innovacion street lot 21; caguas west industrial park; caguas, 00725
• Manufacturer Contact: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 17831608
• MDR Text Key: 324432444
• Report Number: 3013394970-2023-00469
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 00389701011813
• UDI-Public: 00389701011813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 610131
• Device Lot Number: 0000338713
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2900450000-2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian