MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	C610135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Date of birth - requested, not provided.Patient sex - no patient involvement.Ethnicity - requested, not provided.Implanted date: no patient involvement.Explanted date: no patient involvement.Initial reporter occupation: manager.The actual device has 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.
Event or Problem Description
The user facility reported that the angio-seal 8fr evolution sheath shattered during deployment.Per the physician 2/3 of sheaths were left in artery in pieces.The patient was sent to surgery to remove pieces of the sheath.The patient condition was good.Procedure outcome was successful.Additional information was received on 26august2021: procedure performed for the patient prior to use of the closure device was a pvc ablation.The sheath size used was an 8fr.There were no difficulties with arterial access, sheath, guidewire, or catheter insertion.A pre deployment angiogram performed.Angio-seal sheath and arteriotomy locator were assembled as recommended without indication of an issue, devices was inserted, and it broke apart upon insertion which caused fragments to be left in artery and complicated removal of device.Patient was in stable condition.Hemostasis was achieved with a femstop to operating room for cutdown.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 8f angio-seal evolution device was returned for product evaluation.The sheath and carrier tube assembly were returned along with the header bag.Upon visual analysis, the sheath shaft broke below the hub of the sheath.The carrier tube assembly was inserted through the sheath hub but not locked.The device sleeve was in the forward lock position and color bands are not exposed.There was yellow discoloration observed on the sheath pieces under the microscope.The complaint sample was subjected to fourier-transform infrared spectroscopy (ftir) and its infrared spectrum of absorption was found that the sample showed degradation indicative of photo-oxidation which occurs upon exposure to radiation like sunlight or other sources of uv light.A corrective and preventive action (capa) has been initiated to investigate this issue in the past and a notification was sent to capa owner.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• Brand Name: 6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 2101 cottontail ln.; somerset NJ 08873
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset NJ 08873
• Manufacturer Contact: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12492005
• Report Number: 2243441-2021-00041
• Device Sequence Number: 4345794
• Product Code: MGB
• UDI-Device Identifier: 00389701011776
• UDI-Public: 00389701011776
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: 10/31/2021
• Device Catalogue Number: C610135
• Device Lot Number: 7749635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMSTOP; GLIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White