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	07/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device 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 the involved 8fr angio-seal device was attempted post 7fr destination removal.The cath lab reports that the anchor did not deploy out of angio-seal sheath.The rt followed correct steps and proceeded to seal; upon the pull back of the angio-seal system, the entire unit came out of the body.It was noticed after site was controlled that the anchor was in the edge of the angio-seal sheath.The patient's condition was stable.The procedure was successful; however, failed closure.Additional information was received on 21jul2020.The procedure performed prior to use of the angio-seal device was an atherectomy of left leg.A 7fr destination was used during the procedure.A pre-deployment angiogram was performed.Everything wen smooth until closure.Hemostasis was achieved by manual pressure.Additional information was received on 28jul2020.The footplate never came out of sheath while deploying.The angio-seal was cut to confirm that the footplate was in the sheath and not in the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One used 8fr angio-seal sts plus was received for product evaluation.The severed hemostasis sheath was returned mated with the carrier tube assembly along with a header bag.The arteriotomy locator was returned as well.No other accessory components were returned.Visual inspection revealed that the locator was bent in a curved shape.The carrier tube was found to be mated with the sheath and the deployment of the sleeve was in full rear lock position with colored bands fully exposed.Microscopic analysis revealed that the anchor was still present within the hemostasis sheath.There was a cut observed in the hemostasis sheath.No other visual anomalies were noted with the device.Functional testing of the device could not be performed since the distal tip of the sheath was cut causing the anchor to be exposed.The cut in the hemostasis sheath was inflicted by the user to verify that the presence of the anchor within the sheath as stated in the complaint description.Ifu states: "note: do not proceed until you are certain that the anchor has been properly deployed (figure 9).If the anchor is improperly deployed, the angio-seal¿ device will not function." based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that failure to position the device sleeve in the full forward lock position or an obstruction to the anchor posting to the distal tip 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: 8F 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: 10384173
• Report Number: 3013394970-2020-00486
• Device Sequence Number: 3447021
• Product Code: MGB
• UDI-Device Identifier: 00389701011851
• UDI-Public: 00389701011851
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 610121
• Device Lot Number: 06099764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 08/08/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/11/2020
• 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: DESTINATION; GLIDEWIRE; DESTINATION; GLIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention