MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	C610134
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2020
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 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 3013394970-2020-00368.
Event or Problem Description
The user facility reported that the angio-seal sheath kinked upon insertion.The case was a left heart catheterization (lhc).A second angio-seal device was attempted and had the same issue.The procedure was completed successfully with manual pressure.There was no patient injury/medical or surgical intervention required.The patient was in stable condition.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One used 6fr angio-seal evolution was returned for product evaluation.The arteriotomy locator was returned mated with the hemostasis sheath along with the header bag.No other accessory components were returned.Visual inspection revealed that the arteriotomy locator was found to be appropriately mated with the hemostasis sheath.Upon examination of the locator/sheath assembly, a few kinks and a bulge surrounding the kink was observed proximal to the blood inlet holes of the sheath.The locator and sheath assembly were longitudinally deformed.There were no anomalies noted with the transition of the sheath and locator.Then, the locator was removed from the hemostasis sheath and it was found to be bent near the blood inlet hole.No anomalies were noted to the distal tip of the locator.No other visual anomalies were noted.Dimensional testing was performed.The outer diameter of the arteriotomy locator was measured and found to be 0.090'' which was within the specification of 0.092" +0.00/-0.02.The outer diameter of the sheath was measured to be 0.116'' which was within the specification of 0.114" +/-0.005".All measurements were within the manufacturer's specifications.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that off-axis compressive and tensile forces applied to the locator/sheath assembly during insertion into the patient's arteriotomy may have caused the reported event.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: 6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset, nj
• MDR Report Key: 10259854
• Report Number: 3013394970-2020-00369
• Device Sequence Number: 14323932
• Product Code: MGB
• UDI-Device Identifier: 00389701011783
• UDI-Public: 00389701011783
• Combination Product (Y/N): N
• 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): 07/10/2020

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: 01/31/2021
• Device Catalogue Number: C610134
• Device Lot Number: 06101216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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: 72 YR