MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 6FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Model Number	N/A
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Patient height: 6ft.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.This report is for the first device reported, for the second device reported that was used on the same patient see mdr 3013394970-2020-00497.
Event or Problem Description
The user facility reported that the involved angio-seal device was stuck in the angio-seal sheath.The angio-seal came all the way out.The estimated blood loss was less than 250cc's.The patient's condition was stable, no issues.There was no patient injury, medical/surgical intervention required.There were no other devices or equipment used with the reported product.Additional information was received on 27jul2020.Both occurrences happened on the same patient.The procedure was peripheral angiogram with intervention using a 7fr sheath.There was difficulty advancing the angio-seal through the angio-seal sheath; it was stuck in the proximal portion of the sheath and removed by using a hemostat.A pre- deployment angio was performed.Manual pressure was used, and hemostasis was achieved.No issues with the patient were noted from the angio-seal.When the first device failed, the second angio seal device was pulled.When the second device failed, manual compression was applied to achieve hemostasis.There were no issues with the patient noted from the angio-seal device.
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.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: 6FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset, nj
• MDR Report Key: 10401222
• Report Number: 3013394970-2020-00496
• Device Sequence Number: 2854437
• Product Code: MGB
• UDI-Device Identifier: 00389701011868
• UDI-Public: 00389701011868
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 610119
• Device Lot Number: 06098315
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 127