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	04/04/2019
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.
Event or Problem Description
The user facility reported that something happened to the tip of the angio-seal device to not allow it to deploy.When they went to deploy the end it would not deploy.Hemostasis was achieved with a second angio-seal device, and the procedure outcome was reported to be fine.There was no patient injury, and there was no medical intervention.The patient was reported to be in stable condition.Additional information was received on (b)(4) 2019.There was nothing unusual about the device when opened or during arterial access.A 7fr sheath was used.Procedure for patient prior to the closure was a lower extremity angiogram.During the final step of deployment it would not work for closure.It seemed like the piece at the tip that should have closed the artery, was missing the disk (anchor).The patient was not harmed.
Additional Manufacturer Narrative
One 8fr angio-seal sts plus device was received for product evaluation.The carrier tube assembly was only returned.No other accessory components were returned.Visual inspection revealed that the deployment sleeve was in forward lock position and the anchor was exposed at the tip of the carrier tube.There were two kinks identified, one of the kink was located near to the device cap and another one was observed at the manufactured slit.The bypass tube was not returned for analysis.No other anomalies were noted.Functional testing was not possible due to the state of the returned device.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 the carrier tube folded over itself during the forward lock movement due to the kink that leading to non-deployment of the anchor.It is likely that the kinks were sustained during the initial insertion of the device into the sheath.However, 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: 8531967
• Report Number: 3013394970-2019-00289
• Device Sequence Number: 1611732
• Product Code: MGB
• UDI-Device Identifier: 00389701011851
• UDI-Public: 00389701011851
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 610121
• Device Lot Number: 06090993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1