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	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not received 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 doctor deployed the angio-seal evolution in the right groin.When the doctor went to release the suture the entire device came out with the collagen, anchor and suture.They held manual compression afterwards.The patient was in stable condition post procedure.The procedure outcome was successful.Additional information was received (b)(6) 2019.The physician performed angiogram pre-deployment.The sheath size was a 8fr.The procedure was a neruo case.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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
• MDR Report Key: 8414292
• Report Number: 2243441-2019-00021
• Device Sequence Number: 11288939
• Product Code: MGB
• UDI-Device Identifier: 00389701011776
• UDI-Public: 00389701011776
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 05/31/2019
• Device Catalogue Number: C610135
• Device Lot Number: 6489413
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 03/22/2019
• 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