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

Catalog Number	C610134
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device has not 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.For this reason, (b)(4) has been referenced in the conclusions section of evaluation codes.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 similar reports 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 angioseal evolution mechanism was stuck and did not deploy correctly.It was reported that the patient condition is stable.It was reported that the patient outcome was successful.Hemostasis was achieved by manual compression.It was reported that the blood loss was less than 10 cc.No surgical or medical intervention needed outside of the normal cath.A standard ik was used with the product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the evaluation results.The actual device was not returned for evaluation.Therefore, the investigation was based on the user facility information and the device history records.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.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation results.With no return of the actual device the exact cause of the reported event cannot be definitively determined.

• Brand Name: 6F ANGIO-SEAL EVOLUTION 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: 6846127
• Report Number: 2243441-2017-00115
• Device Sequence Number: 68273
• Product Code: MGB
• UDI-Device Identifier: 25415067002833
• UDI-Public: 25415067002833
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 09/06/2017

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: 03/31/2018
• Device Catalogue Number: C610134
• Device Lot Number: 5932855
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 09/18/2017; 11/03/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 10/16/2017; 11/20/2017
• 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