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 Information (3190)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been 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 8f evolution device was used during a carotid femoral access case.The footplate did not come out, and manual pressure was applied to complete the case successfully.
Additional Manufacturer Narrative
One 8 fr angio-seal evolution device was received for product analysis.The evolution device and the hemostasis sheath were returned for analysis.No accessory components were returned.The hemostasis sheath was returned separately, and the bypass tube was present into the hemostatic valve.Visual inspection revealed that the deployment sleeve was in the rear lock position with the color bands fully exposed.There was a kink identified in the carrier tube just distal from the hub of the carrier tube.The anchor and swollen collagen were exposed as can be seen in the attached pictures.No other visual anomalies were noted with the returned device.Functional testing could not be possible due to the state of the returned device.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that after non-deployment pullout, the sheath was attempted to be removed manually.However, 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: 8743634
• Report Number: 2243441-2019-00044
• Device Sequence Number: 13785577
• Product Code: MGB
• UDI-Device Identifier: 00389701011776
• UDI-Public: 00389701011776
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 11/30/2019
• Device Catalogue Number: C610135
• Device Lot Number: 6774413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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