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, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Weight - (b)(6).Ethnicity - requested, not provided.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.
Event or Problem Description
The user facility reported the involved 8fr angio-seal device failed.The patient's condition was stable, positive patient outcome.There was no patient injury, medical/surgical intervention required.Additional information was received on 08jul2020.The procedure being performed was an abdominal angiogram with angioplasty and stent placement.A 7fr sheath was used.A pre-deployment angiogram was performed.The device felt like the plug did not catch or dislodged.While holding the device taught and pushing the green plastic tube down; it suddenly felt like the device moved (loosed up and gave more string).An 180cm angled glide wire was used.Hemostasis was achieved by manual pressure.
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 device was received for product evaluation.The carrier tube assembly was returned mated with the hemostasis sheath in a fully deployed state.The arteriotomy locator was returned as well.Visual inspection revealed that the hemostasis sheath was mated with the carrier tube assembly.The deployment sleeve was found in the full rear lock position with color bands fully exposed.The suture was exposed at the distal tip of the hemostasis sheath and it had a clear shrink wrap marker present.The distal end of the suture was inspected under the microscope and it appeared to be cut manually with a sharp blade.There were no collagen, anchor and tamper tube returned.The overall device condition is consistent with full deployment.No other visual anomalies were noted.The tamping sequence was completed, and suture was cut manually at the end of deployment.The anchor nor the tamper tube were returned for analysis.The suture was found to be completely released from the spool housed within the device hub, thus, the suture spooling mechanism did not likely contribute to the reported allegation.The returned components indicate that the device was properly deployed.A review of the device history record of the product code/lot# combination was conducted with no findings.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of normal product.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: 10313494
• Report Number: 3013394970-2020-00438
• Device Sequence Number: 3222800
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 610121
• Device Lot Number: 06097921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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: 180CM ANGLED GLIDE WIRE; 180CM ANGLED GLIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 40