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

Catalog Number	C610134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Race - requested, not provided.Explanted date: device was not explanted.Initial reporter occupation- interventional supervisor.The actual device was not 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 device appeared to deploy fine, however after cutting the string at the end, the angio-seal material protruded out of the skin and a hematoma formed.It appeared that it did not tamp down over the arteriotomy site.There were no issues with access.They started with a 5-french short procedural sheath and exchanged for a 6-french shuttle.A pre-deployment angiogram was performed.There were no issues with using the device.Ultimately, pressure was held for approximately 30 minutes to achieve hemostasis.There was no noticeable damage to the device.It looked ok and seemed to deploy ok until the very end.The patient was in stable condition.The procedure outcome was successful.Additional information was received on 16sept2021.The procedure was a pipeline placement/neuro aneurysm embolization.
Additional Manufacturer Narrative
This report is being submitted, 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 could be confirmed, for hematoma.Since a hematoma was observed, as per allegation.Manual pressure was applied.And no further issue was experienced.Based on the available information, the exact cause of the issue 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 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: 12591443
• Report Number: 2243441-2021-00046
• Device Sequence Number: 3892749
• Product Code: MGB
• UDI-Device Identifier: 00389701011783
• UDI-Public: 00389701011783
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 02/28/2022
• Device Catalogue Number: C610134
• Device Lot Number: 7895116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Hispanic