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	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
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.A review of the device history record of the product code/lot# combination was conducted with no findings.One 6f angio-seal sts plus was received for product evaluation.Only the carrier tube assembly was returned.Visual inspection revealed that the bypass tube was found protecting the anchor of the carrier tube assembly.The collagen had expanded from the slit due to contact with dried bloodlike substance or moisture.The deployment sleeve of the device was in a full forward lock position.No other visual anomalies were noted.The manufactured slit was unable to be measured since the collagen had expanded.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the device had prolonged exposure to blood like substances or moisture leading to the reported event.
Event or Problem Description
The user facility reported that there was a large split in the distal end of the angio-seal shaft just proximal to the bypass tube.The angio-seal was not able to be advanced into and through the bypass tube so it was not able to be deployed.Another angio-seal was then pulled and successfully deployed.The procedure was completed successfully and the patient is doing good in stable condition.Additional information was received 13december2019: the procedures performed was an embolization procedure using a 6fr sheath.

• 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: 9559111
• Report Number: 3013394970-2019-01099
• Device Sequence Number: 19434973
• Product Code: MGB
• UDI-Device Identifier: 00389701011868
• UDI-Public: 00389701011868
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 01/07/2020

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 610119
• Device Lot Number: 06097931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1