MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 8FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 3013394970-2019-00737.
Event or Problem Description
The user facility reported that the plastic tip that houses the intra-arterial footplate was dislodged before inserting it into the angio-seal sheath.This happened twice causing the footplate to be exposed and floppy before inserting.The third angio-seal device was used properly and worked per usual.The first two devices were not inserted into the patient.The ir manager and the doctor both believe this was probably due to user error.Blood loss was less than 250cc.There was no injury to the patient.The procedure outcome was successful.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to correct sections d1 and which were inadvertently reported incorrectly, and to provide the completed investigation results.One 8fr angio-seal sts plus carrier tube was returned for product evaluation.No other accessory components were returned.Visual inspection revealed that the deployment sleeve of the device was found in the forward lock position.There was no evidence of a bend or a kink in the carrier tube assembly material.The bypass tube was found detached from the main body of the device and the anchor was exposed.The collagen sponge was expanded at the tip of the tube as it was likely to exposed to blood.Since the bypass tube was not returned, no functional testing was possible.Based on the provided information and investigation results, there is no definitive 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: 8FR ANGIO-SEAL STS PLUS 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: 9125764
• Report Number: 3013394970-2019-00738
• Device Sequence Number: 11346089
• Product Code: MGB
• UDI-Device Identifier: 00389701011851
• UDI-Public: 00389701011851
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/26/2019

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: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 610121
• Device Lot Number: 06093741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1