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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted date: device was not explanted.The actual device was not 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 an angio-seal device was used after the initial procedure.Ultrasound (us) guidance of the right femoral artery (rfa) using a teleflex vsi micro-access kit then a 5fr terumo pinnacle 10cm sheath.A common femoral artery (cfa) angiogram of access site was performed and then they switched for a 7fr destination 45cm length sheath to go up and over for left common femoral artery (lcfa) plain old balloon angioplasty (poba) intervention.Seven thousand units of heparin was given at the beginning of the intervention and fifty units of protamine was given at the end of the case to reverse the heparin.The destination sheath was pulled back over the.035 wire and then the angio-seal sheath was inserted over the wire (otw).The angio-seal dilator and 180 cm.035 wire were removed.The angio-seal device inserted and clicked together and back with sheath when pulling back and compacting with the compaction tube there was no oozing or bleeding.When they pulled the compaction tube back, they got arterial type flow, they compacted again and when they pulled back there still was arterial type flow.Manual pressure was held for five minutes per sheath size; a total of thirty-five minutes.The patient was stable.There was no patient injury/medical or surgical intervention required.The procedure was successful, however the closure device was unsuccessful.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.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: 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: 9829150
• Report Number: 3013394970-2020-00106
• Device Sequence Number: 679417
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 610119
• Device Lot Number: 06099539
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .035 WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR