MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 6FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: unknown due to unknown date of event.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 first device reported, for the second device reported that was used on the same patient see mdr 3013394970-2020-00221.
Event or Problem Description
The user facility reported that two angio-seal sheaths were bent upon removal from the packaging.The physician did not want to use or deploy the devices for the patient's safety.Additional information was received on 17mar2020.The first device was opened, and the sheath was noted to be bent.The doctor then opened a second angio-seal device from the same lot number, and it was bent right out of the package as well.A third angio-seal device was opened, and the procedure was completed with no issues.There were no issues for the patient and the patient was in stable condition.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One used 6fr angio-seal sts plus device was returned for product evaluation.The kinked arteriotomy locator, hemostasis sheath and plastic tray were returned along with two header bags.Visual inspection revealed that there was a kink identified at blood inlet hole of the arteriotomy locator.There were no anomalies or deformation noted on the hemostasis sheath.The bypass tube was found placed within the hemostatic valve.No other visual anomalies were noted.Dimensional testing was performed.The outer diameter of the arteriotomy locator was measured to be 0.091" which was within the manufacturer specification of 0.092" +0.000/-0.002.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 an off axis force to the arteriotomy locator while removing the locator from the tray 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: 6FR ANGIO-SEAL STS PLUS 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: 9950000
• Report Number: 3013394970-2020-00220
• Device Sequence Number: 3131457
• Product Code: MGB
• UDI-Device Identifier: 00389701011868
• UDI-Public: 00389701011868
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 610119
• Device Lot Number: 06099841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1