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 Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
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.For this reason, evaluation code has been referenced in the conclusions.A review of the device history record of the product code/lot# combination was conducted with no findings.This report is for the fourth device that was used on the same patient.See mdr's 3013394970-2018-00305, 3013394970-2018-00306, 3013394970-2018-00307 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 250cc.The procedure outcome was successful.Manual compression was used to close the artery.
Additional Manufacturer Narrative
One 8fr angio-seal sts plus was returned for evaluation.One carrier tube assembly was returned.The bypass tube was not returned.The collagen within the carrier tube was slightly swollen.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 = 0.1019" and tamper tube outer diameter = 0.0794".All measurements were within the specifications defined in the engineering drawings active at the time of manufacturing.There is no evidence that this event was related to a device defect or malfunction.Based on evaluation of the returned carrier tube assembly, no anomalies could be detected during microscopic and dimensional inspection.

• 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: 7553879
• Report Number: 3013394970-2018-00308
• Device Sequence Number: 1277772
• 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
• 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?: Yes
• 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: 07/11/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention