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

Catalog Number	C610135
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Explanted date: device was not explanted.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 when deploying the angio-seal device in the right common femoral artery after an iliac artery intervention, after the device deployed a piece of the plastic of the product came loose.It did not prevent a good closure.The patient was in stable condition.A 7 fr.Destination sheath was used.There was no patient injury/medical or surgical intervention required.The procedure outcome was completed.Additional information was received 29september2021: the piece that came loose is at the top of the tamp tube on the evolution.There were no difficulties with arterial access, sheath, guidewire, or catheter insertion.Pre deployment angiogram was performed.No issues with insertion, deployment, or withdrawal of the device.Hemostasis was confirmed to be completed with the device.
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 8 fr angio-seal evolution device was received for product evaluation.The hemostasis sheath was returned mated with the carrier tube assembly along with the header bag.No other components were returned for evaluation.Upon visual analysis, there was bloodlike substance found on the device.There was a kink observed, on the hemostasis sheath shaft just below the hub.The tamper tube is completely released from the device, but still attached to the suture.The device sleeve was in rear lock position with the color bands exposed.A portion of the carrier tube shaft appeared to be cut and located over the suture proximal to the tamper tube.The device body is separated from the hemostasis sheath hub.And subjected to microscopic analysis.There was plastic deformation caused by applying tensile forces at the cut portion of the carrier tube shaft.Additionally, hemostat marks were seen on the carrier tube shaft distal end.Based on the evaluation performed.The complaint can be confirmed, for the damaged carrier tube housing.The tamper tube was also completely released from the device.The exact cause of the breakage seen on the carrier tube shaft is unknown.However, it appeared to be caused, during deployment of device.As there are hemostat marks on the tube.The exact cause of the event experienced by the user cannot be determined.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: 8F 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: 12634690
• Report Number: 2243441-2021-00053
• Device Sequence Number: 11675341
• Product Code: MGB
• UDI-Device Identifier: 00389701011776
• UDI-Public: 00389701011776
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: C610135
• Device Lot Number: 7858285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• 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: 7FR DESTINATION; 7FR DESTINATION
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American