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

Model Number	N/A
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.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.This report is for the first event reported, for the second event reported with the same device that was used on the same patient see mdr 3013394970-2020-00652.
Event or Problem Description
The user facility reported that the angio-seal device did not lock the footplate in place as the second click would not engage, however, they continued to deploy the device, and a frayed suture was also noted.The patient remained in stable condition with no signs of bleed or hematoma.There was no patient injury/medical or surgical intervention required.The estimated blood loss was less than 250cc.The procedure outcome was successful.Additional information was received on 24sept2020.The procedure performed prior to the use of the angio-seal device was a tavr procedure.A 6fr procedural sheath was used.Insertion of the device was not notable, however the anchor failed to lock in place.Hemostasis was achieved with the reported product device, and with assisted manual (prophylactic) compression.Manual compression was performed not in response to bleeding, but due to the uncertainty.Additional information was received on 30sept2020.The vessel diameter was greater than 5mm, no calcification or atherosclerotic disease noted.The access was uncomplicated, a 5fr micro-puncture and ultrasound guided access were used.The device anchor did not appear to lock in place, as the second click was never confirmed.
Additional Manufacturer Narrative
This reported event has been deemed not reportable based off the investigation of the actual device; inspection of the returned sample upon receipt found that the device had been completely engaged in rear lock position and both color bands were fully exposed.There were no anomalies noted with the device locking.The overall condition of the device was in a fully deployed state.The device involved in this complaint has been verified to be of normal product; therefore, is not a reportable event.

• Brand Name: 6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset NJ 08873
• MDR Report Key: 10693128
• Report Number: 3013394970-2020-00651
• Device Sequence Number: 14436755
• Product Code: MGB
• UDI-Device Identifier: 00389701011783
• UDI-Public: 00389701011783
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/16/2020

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: 12/21/2020
• Device Model Number: N/A
• Device Catalogue Number: C610134
• Device Lot Number: 06100699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 59