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

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.One each of the following were received: locator, hemostasis sheath and carrier tube assembly.The arteriotomy locator was mated with the hemostasis sheath but was snapped on completely.There was blood like substance noted on the sheath and locator.The carrier tube assembly appeared to be unused but was not within its original packaging when returned.Upon microscopic inspection, it was discovered that the hemostasis sheath was bent and deformed at one blood inlet hole.There was also significant dried blood and tissue like debris found near the holes.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause of the reported event cannot be definitively determined based on the investigation, the likely cause of the event is either kinking of the sheath and locator assembly or blocking of the inlet holes by the some tissue or a combination of both.The sheath can kink due to extreme off axis insertion or excessive angulation after insertion into the anatomy.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.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 no/inadequate blood return when using the angio-seal vip device during an interventional catheterization.The following information was provided by the user facility: case was complete except for closure device.Once the arteriotomy locator was inserted into the patient, there was no visible blood flash.So the device was pulled out and another angio-seal was opened.The second angio-seal was successful.The procedure outcome was reported to be successful.Additional information was reported on 10/17/2017: blood loss was reported to be minimal.The patient was reported to be fine and stable.No other devices were used.

• Brand Name: 6F ANGIO-SEAL VIP 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: 7016889
• Report Number: 3013394970-2017-00504
• Device Sequence Number: 19084031
• Product Code: MGB
• UDI-Device Identifier: 05414734054591
• UDI-Public: 05414734054591
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

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: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 610130
• Device Lot Number: 5706653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1