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 Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Hematoma (1884); No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - weighed (b)(6).One angio-seal device was returned for evaluation.The carrier tube assembly was returned with the collagen and anchor visible at the end of the suture.No locator or hemostasis sheath was returned.The collagen was covered in blood like substance but was not tamped into a knot with the anchor.Based on the returned device, the exact root cause of anchor not setting in the artery could not be determined.The returned device suggests that the anchor pullout event occurred before the tamping step could be performed.The absence of mated hemostasis sheath may be a potential cause of the event.Possible causes could also be the patient anatomy, vascular heath, user technique or an obstruction preventing the anchor from posting.The anchor pulled out of the artery before the collagen could be tamped.At this time, no conclusion can be drawn as to the cause of the reported event.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.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 that upon deployment of angio-seal into femoral artery, the anchor did not set inside the artery and entire system pulled out while physician was attempting to tamp collagen down.It was reported that the patient occurred a hematoma and that additional manual pressure was required.It was reported that the patient condition was stable.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation.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.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: 6952764
• Report Number: 3013394970-2017-00441
• Device Sequence Number: 682430
• Product Code: MGB
• UDI-Device Identifier: 05414734054591
• UDI-Public: 05414734054591
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 10/16/2017

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: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 610130
• Device Lot Number: 5870170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 11/01/2017
• 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
• Patient Age: 74 YR
• Patient Weight: 120