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 Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the complaint sample could not be performed due to the sample being unavailable.Without a sample available for product analysis the cause of this event is unable to be determined.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 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.
Event or Problem Description
The user facility reported: pad case, accessed right femoral artery, treated contralaterally.Balloon angioplasty of right sfa, followed by drug-eluding balloon and stent.Device did not deploy properly.Physician was unable to see the green marker on the suture and was unsure if collagen was advanced enough to seal the artery against the anchor.The patient is stable.The procedure outcome was successful.Additional information was received on 6/16/17.The device was able to seal the artery, so the anchor, suture and collagen are in the patient.Hemostasis was achieved by the device and the blood loss was less than 250cc.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.With no device return 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: 6714138
• Report Number: 2243441-2017-00064
• Device Sequence Number: 531383
• Product Code: MGB
• UDI-Device Identifier: 05415067002839
• UDI-Public: (01)05415067002839(17)180228(10)5918914
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/14/2017

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: 02/28/2018
• Device Catalogue Number: C610134
• Device Lot Number: 5918914
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR