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

Catalog Number C610134

Device Problems Detachment Of Device Component (1104); Device Inoperable (1663); Activation, Positioning or Separation Problem (2906)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was not returned 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 involved product/lot # combination was conducted with no relevant findings.A search of the complaint file found one other report with the involved product code/lot# combination.See mdr 2243441-2017-00122 for patient one & 2243441-2017-00123 for patient two.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported a tamping mechanism issue when using the involved device.Follow up communication with the user facility reported: on three different patients the reported lot number/angioseal device all had issues.The tapinot tube didn't function on one, the real mechanism failed on the other and the cologen plug fell out of the other angioseal.All three patients were reported to be stable.Successful outcomes from the procedures.Additional information was received on 8/24/17 update: it was reported that the device came out of the artery (along with the foot pedal/collagen plug) as they were deploying the vcd.It was reported that it didn't actually "fall out" as first reported.The whole device came out when it was being deployed.The complete vcd came out.It was used post peripheral arterial disease interventional case.A pre deployment angiograph was performed.Hemostasis was achieved by manual compression.The patient was reported to be stable.The procedure outcome was reported to be successful.

Manufacturer Narrative

This report is being submitted as follow up no.1.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.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 based on the available information.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 EVOLUTION VASCULAR CLOSURE DEVICE, US
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 2101 cottontail ln.; somerset NJ 08873
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 2101 cottontail ln.; somerset NJ 08873
• Manufacturer Contact: terry callahan ; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6865825
• MDR Text Key: 86161742
• Report Number: 2243441-2017-00124
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: C610134
• Device Lot Number: 5918914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR