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	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.(b)(4).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 the involving angio-seal device was used.An ultrasound guidance was used for at a left common femoral artery access with a 18g needle and.035 wire 4f boston supersheath.These were inserted and a left common femoral artery (lcfa) angio imaging was taken upsized for a 6f terumo pinnacle.There was no disease within 5mm of the access site.The access location was an ideal spot for a left iliac intervention balloon and stein.The sheath was exchanged for a 7f 45cm destination to go up and over to the right side for the right iliac intervention.The destination device was pulled back over the.035 wire, the angio-seal sheath was inserted over the angio-seal dilator and 180cm of the.035 wire was removed.The angio-seal device was inserted and was clicked together and back with the sheath, when pulling back the device and compacting with the compaction tube there was no oozing or bleeding.When the compaction tube was pulled back, they got an arterial flow.So, they compacted again and when they pulled back again there was still an arterial flow.Ultimately, they had to hold manual pressure for 5 minutes per sheath size so total of 35 minutes.The patient was stable, no injury or complication occurred due to the failure.The procedure was successful although no device was able to be used for closure.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, 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: 9810737
• Report Number: 3013394970-2020-00109
• Device Sequence Number: 1299890
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 610119
• Device Lot Number: 06100460
• 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: 03/10/2020
• Supplement Report FDA Received Date: 03/20/2020
• 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: 18G NEEDLE AND .035 WIRE 4F BOSTON SUPERSHEATH; 6F TERUMO PINNACLE, 7F 45CM DESTINATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR