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

Model Number	N/A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
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 used on the patient; see mdr 3013394970-2019-00758 for the first device reported that was used on the same patient.
Event or Problem Description
The user facility reported that two angio-seal devices would not go in for the footplate to pull back so the whole thing came out.On the third angio-seal device, it worked.Two of the devices has an issue.The patient was in stable condition.The procedure outcome was a success.Additional information was received 13 september 2019: the two devices were used during the same procedure and was the same patient.The patient was having a peripheral procedure using a 7fr procedural sheath.A pre-deployment angiogram was performed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 and to provide the completed investigation results.One used 8f arteriotomy locator was received for product evaluation.No other accessory components were returned.Visual inspection revealed there was no damage or deformation noted on the returned locator.No other visual anomalies were noted.The actual carrier tube with the footplate (anchor) was not returned for evaluation.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: 8F 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: 9161165
• Report Number: 3013394970-2019-00759
• Device Sequence Number: 11339828
• Product Code: MGB
• UDI-Device Identifier: 00389701011851
• UDI-Public: 00389701011851
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 610121
• Device Lot Number: 06095525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1