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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Necrosis (1971); Swelling (2091)
Date of Event	06/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight: (b)(6).The actual device has not returned to the manufacturing facility 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 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.(b)(4).
Event or Problem Description
This report is being submitted in response to user facility medwatch report (b)(4) was received from the fda on august 28, 2017.The event description states the following: "patient underwent a heart catheterization with angio-seal vip 6f to right groin over one month ago.The patient underwent heart catheterization from a right femoral approach an angio seal closure device less than 10 days ago.The patient presented with signs of right groin infection including multiple areas of erythema and small pustules.Act angiogram revealed phlegm on versus fluid collections.Upon entering the subcutaneous tissue, multiple pockets of purulent fluid were encountered.Multiple cultures of this fluid were sent.Tomramycin and vancomycin antibiotics beads were placed under the muscle flap directly onto the arterial wall and on top of the muscle flap.Infected necrotic tissue was sharply debrided from the subcutaneous tissues.The wound was then irrigated with bacitracin and polymyxin antibiotic irrigation.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device has not been returned for evaluation.No evaluation could be conducted due to the device not being returned.There is no evidence that this event was related to a device defect or malfunction.With no return of the actual device the exact cause of the reported event cannot be definitively determined.

• 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: 6893037
• Report Number: 3013394970-2017-00381
• Device Sequence Number: 699432
• Product Code: MGB
• UDI-Device Identifier: 15414734054598
• UDI-Public: 15414734054598
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 09/26/2017

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 Model Number: N/A
• Device Catalogue Number: 610130
• Device Lot Number: 5950786
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 09/26/2017; 10/26/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 10/18/2017; 11/16/2017
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 76