MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Blood Loss (2597)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was not returned for evaluation.Therefore, the investigation was based on the user facility information and the device history records.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 that the black compaction marker on the angio-seal vip was not visualized during deployment, which led to overtightening of the device.Patient was having a cerebral aneurysm coiling procedure.The following information was provided by the user facility: during deployment of the angio-seal vip, the black compaction marker was not easily visible, which the physician believed led to overtightening of the device.The device was deployed.Later that evening the patient began bleeding and developed an abdominal wall hematoma.The hematoma was compressed and a femostop was applied to the puncture site.The patient bled again sometime later, and again a third time.The patient went into cardiac arrest the third time she bled.The patient received multiple blood products and transfusions due to blood loss.She was taken to surgery and a hole was found at the arteriotomy site with no evidence of the angio-seal.Sometime after the surgery the patient had a stroke.She has completed rehab for her stroke and has returned to the hospital for three additional operations to remove residual blood from her abdominal wall hematoma.Physician is a long time experienced user.Blood loss was reported to be greater than 250cc.Patient condition is reported to be stable, with a small residual hematoma and some cognitive defects from the stroke.Had surgery for repair of the femoral artery and multiple surgeries for evacuation of abdominal wall hematoma.Additional information was received on (b)(6) 2017: the second and third hemorrhages occurred the evening of the second day in the icu, or the day after the procedure.Patient had hemostasis until early am after procedure when patient became agitated.Compression and femostop applied.Successful deployment.Patient tolerated well.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.There is no evidence that this event was related to a device defect or malfunction.With no device return 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: 8F 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: 6810730
• Report Number: 3013394970-2017-00319
• Device Sequence Number: 18866816
• Product Code: MGB
• UDI-Device Identifier: 05415067002853
• UDI-Public: 05415067002853
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/22/2017

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: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 610131
• Device Lot Number: 5894816
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 10/12/2017
• 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: Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 68