MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 6F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Model Number	N/A
Medical Device Problem Codes	Kinked (1339); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned to the manufacturing facility for evaluation.No evaluation could be conducted due to the device not being returned.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.A search of the complaint file did find two other reports with the involved product code/lot# combination.The same user facility reported a similar events for another device with the same product code/lot number combination, see mdr3013394970-2017-307, mdr 3013394970-2017-00308, and mdr 3013394970-2017-00310.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, (b)(4) has been referenced in the conclusions section of evaluation codes.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported that doctor had four angio-seal sts devices where the device was kinking when attempting to deploy.Each time they had to cut the device to deploy the angio-seal.The patient condition was reported to be fine.Additional information was received on 7/28/2017: the doctor had issue with deploying 6fr sts angioseal, four consecutive devices failed.It was reported that the sheath gets stuck inside the patient once the dilator and wire are taken out and both devices are clicked together when she pulls back the sheath is stuck in the patient and she has to cut the suture to pull the sheath out.It was reported that the patient condition was stable with no issues.It was reported that there were no issues with the procedure outcome.Additional information was received on 8/2/2017: hemostasis was able to be achieved with the device once the suture was cut.Blood loss was reported to be less than 250 cc.It was reported that the procedure outcome was successful.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the provide the completed investigation.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: 6F 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: 6812747
• Report Number: 3013394970-2017-00309
• Device Sequence Number: 992796
• Product Code: MGB
• UDI-Device Identifier: 05415067002860
• UDI-Public: 05415067002860
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/23/2017

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: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 610119
• Device Lot Number: 5941567
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1