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	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	09/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 one similar 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 that the device was delivered per ifu and failed to seal.Manual pressure was held following failure and hemostasis was achieved.It was reported that the patient condition was stable.It was reported that the procedure outcome was successful.Additional information was received on 9/11/2017: it was reported that the blood loss was less than 250cc.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the actual device evaluation and the completed investigation.One 6f angio-seal vip was returned for evaluation.The locator, hemostasis sheath and the hub of carrier tube assembly was returned.The carrier tube was cut and only the hub was returned.The remaining portion of the carrier tube or anchor or suture was not returned.The carrier tube hub was disassembled and the tensioner hub frame was found to have excess blood like substances coating on it.The end on the cut suture was analyzed under the microscope, and it was determined that it was a blade cut.It is likely that the device was manually cut near the carrier tube hub to remove the device from the operation site.The exact cause of the event is unable to be determined with the available information but since all the turns of the suture were intact within the suture hub and there was excessive blood like substance found on the tensioner frame, it is likely that suture lock up was the cause of the adverse event.Based on the state of the returned device, it is unable to be determined if the device was deployed as intended since the anchor and collagen were not returned.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 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: 6915010
• Report Number: 3013394970-2017-00426
• Device Sequence Number: 16439475
• Product Code: MGB
• UDI-Device Identifier: 05414734054591
• UDI-Public: 05414734054591
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2017

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: 02/26/2018
• Device Model Number: N/A
• Device Catalogue Number: 610130
• Device Lot Number: 5920099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/02/2017
• 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