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	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(6).The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot# combination was conducted with no findings.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 3013394970-2020-00653.
Event or Problem Description
The user facility reported that the physician experienced an unknown deployment issue when using the angio-seal device.The physician tried a second angio-seal device on the same patient and had the same deployment issue.There was no patient injury/medical or surgical intervention required.The patient was reported to be in good condition.Additional information was received on 30sept2020.The type of procedure performed was a percutaneous coronary intervention using a 6fr procedural sheath.An angiogram was performed.The anchor and collagen did not deploy.Hemostasis was achieved by manual compression.The patient was reported to be in stable condition.

• 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: 10701274
• Report Number: 3013394970-2020-00654
• Device Sequence Number: 3058682
• Product Code: MGB
• UDI-Device Identifier: 00389701011783
• UDI-Public: 00389701011783
• Combination Product (Y/N): N
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: C610134
• Device Lot Number: 06099541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR