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 Code	Kinked (1339)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has been returned to the manufacturing facility 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 relevant findings.A search of the complaint file did not find any other report 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 mdr3013394970-2017-308, mdr 3013394970-2017-00309, and mdr 3013394970-2017-00310.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 8/2/17: 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 completed investigation results.One used 6fr angioseal sts plus device was received for evaluation.The device was returned with the arteriotomy locator, a portion of the carrier tube assembly and the green tamping tube exposed.The returned components were subjected to visual analysis where a blood like substance was found on all returned components.The device cap and the hemostatic sheath were mated and the deployment sleeve was in the rear lock position.There was evidence that the carrier tube distal to the device cap appeared severed, which is consistent with the bail out method.There was no suture exposed.The distal portion of the severed carrier tube assembly was inspected for any presence of the suture or anchor; neither was found.The hemostatic sheath was separated from the device cap.The deployment sleeve was then removed from the device cap.The tensioner was then removed from the device cap and examined for any obstacles that would have prevented the suture from releasing.No visual obstructions were noted.Several complete turns of the suture were remaining on the spool.A pair of tweezers was taken to dislodge the suture from the spool.The suture easily unspooled from the tensioner.The complaint could not be confirmed, as the suture was able to be unspooled with very little resistance.The returned device does indicate that the user deployed the bailout method and which indicates that some form of resistance occurred, but was not due to the spool malfunctioning.Additionally no obstructions were noted with either the tamping tube or carrier tube assembly.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: 6812969
• Report Number: 3013394970-2017-00307
• Device Sequence Number: 16578171
• 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,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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 08/28/2017; 09/26/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 09/26/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1