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, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
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 the introducer sheath and arteriotomy locator was placed in the patient over the wire.The wire and arteriotomy locator came out, the device with the bypass tube was initially inserted in the sheath; however, it did not advance.The patient was in stable condition and the procedure was successful using a second device.Additional information was received on 26sep2019.The procedure was a right external iliac stent placement via left common femoral artery (cfa) access using a 5fr 45 cm sheath.A left common femoral artery angiogram was performed prior to closure deployment.
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 6fr angio-seal sts plus device was received for product evaluation.Only the carrier tube assembly and header bag were returned for analysis.Visual inspection of the carrier tube assembly revealed that there was blood-like substance all over the device, the deployment sleeve was in the manufacturing position (forward lock position), and the color bands were not exposed.There were multiple kinks noted at the proximal portion of the carrier tube assembly.The bypass tube was still attached at the distal tip of the carrier tube and collagen was found expanded due to contact with blood-like substance.There were also kinks on the carrier tube at the manufacturing slit.Functional testing was not possible due to the state of the returned device.Ifu states: "confirm that the device sleeve has remained in the rear holding position.Carefully grasp the angio-seal device at the bypass tube.Cradle the angio-seal carrier tube in the palm of the hand and, with the reference indicator facing up, slowly insert the bypass tube and carrier tube into the hemostatic valve".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 the kinks were from the handling or inserting of the device into the sheath; multiple kinks could be the result of trying to insert the carrier tube after the first kink.However, 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; 2101 cottontail ln.; somerset NJ 08873
• MDR Report Key: 9217839
• Report Number: 3013394970-2019-00800
• Device Sequence Number: 19372447
• Product Code: MGB
• UDI-Device Identifier: 00389701011868
• UDI-Public: 00389701011868
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/22/2019

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: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 610119
• Device Lot Number: 06096929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 99