MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
The user facility reported that the angioseal portion separated from the sheath portion after deployment of the footplate.When they went to pull back and send the plug down the device was cut and they manually pushed the plug (collagen) down.It was reported that held pressure on patient for little bit just to be sure but collagen plug seem to have held.The patient condition is stable and the procedure outcome was successful.
Additional Manufacturer Narrative
One used 8fr angioseal vip device was received for product evaluation.The device was returned with the tamper tube and hemostatic sheath.The returned device was subjected to visual analysis where blood like substance was observed on the device.The carrier tube assembly was returned separated from the hemostatic sheath.The deployment sleeve was in the rear lock position with the color bands fully exposed.There was a slight bend in the carrier tube assembly.The bypass tube could be seen dislodged on the carrier tube just distal to the device cap.The tamping tube had been removed from the carrier tube assembly.The hemostatic sheath was then examined under microscopy.There was deformation on the hub of the hemostatic sheath indicative of the deployment sleeve being forcibly removed from the hemostatic sheath.Based on the returned components, the complaint could be confirmed for detached separated as there was damage to the hemostatic sheath hub.The damage observed indicated that the hemostatic sheath and carrier tube assembly had once been properly mated.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: 8F ANGIO-SEAL VIP 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: 7284149
• Report Number: 3013394970-2018-00052
• Device Sequence Number: 13747536
• Product Code: MGB
• UDI-Device Identifier: 05415067002853
• UDI-Public: 05415067002853
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 610131
• Device Lot Number: 5866016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/23/2018
• 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: 65 YR