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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not 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.This report is for one of the four involved devices reported, before use, on the same patient.See mdr's 3013394970-2018-00305, 3013394970-2018-00306, 3013394970-2018-00308 for the other three reported events.
Event or Problem Description
The user facility reported they used four different angio-seal sts 8fr devices.The customer had issues with the collagen/bypass tube staying in place.They did not attempt to place the first three devices in the patient.The customer said the device was coming apart near the collage/bypass tube.The customer used the fourth device on the patient.Upon deployment the customer noticed that the device was coming apart and did not have good hemostasis.The customer held pressure on the patient and that controlled the bleeding.Estimated blood loss was less than 250 cc.The procedure outcome was successful.Manual compression was used to close the artery.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information.It was initially reported the device was not available.However, the device was returned.Therefore, sections have been updated to reflect the device return.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation.One 8fr angio-seal sts plus was returned for evaluation.One carrier tube assembly was returned.The bypass tube was returned separately.The collagen within the carrier tube was slightly swollen and crusted with blood like substances.The anchor was exposed due to detachment of the bypass tube.There was no damage noted on the mating wings of the carrier tube hub.The aluminum pouch was not returned.The following measurements were carried out: carrier tube outer diameter = 0.1022", tamper tube outer diameter = 0.0794", bypass tube proximal max od = 0.3120", bypass tube distal id = 0.110.All measurements were within the specifications defined in the engineering drawings active at the time of manufacturing.The ifu states: "remove the angioseal device contents from the foil package by opening the package at the arrow indicator taking care to pull the foil seal apart completely before removing the angioseal device." there is no evidence that this event was related to a device defect or malfunction.Based on historical data, records have shown that if the polyfoil pouch is not opened completely when attempting to remove the carrier tube assembly, the bypass tube can become dislodged.However, without the aluminum foil, 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: 7553880
• Report Number: 3013394970-2018-00307
• Device Sequence Number: 13504163
• Product Code: MGB
• UDI-Device Identifier: 00389701011851
• UDI-Public: 00389701011851
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2018

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: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 610121
• Device Lot Number: 06085475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 05/29/2018; 07/05/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 06/19/2018; 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1