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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight - (b)(6).Explanted date: device was not explanted.Additional patient information: height 167 cm.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 an expired angio-seal device was deployed during a pci (percutaneous coronary intervention) procedure.The box and package were correctly labeled.The patient has not presented any problems.The health care provider who deployed the device did not detect any issues during the deployment.The patient's condition was reported to be good the next day during a follow up.The patient was stable.The procedure outcome was successful.There were no other devices or equipment used with the angio-seal device.
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: 8256242
• Report Number: 2243441-2019-00001
• Device Sequence Number: 16623234
• Product Code: MGB
• UDI-Device Identifier: 00389701011776
• UDI-Public: 00389701011776
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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: 09/30/2018
• Device Catalogue Number: C610135
• Device Lot Number: 6173216
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR