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

Catalog Number C610134

Device Problems Component Falling (1105); Difficult or Delayed Positioning (1157); Device Inoperable (1663)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2017

Event Type  malfunction  

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.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.A further investigation has been initiated.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 reports with the involved product code/lot# combination.See mdr 2243441-2017-00123 for patient two & 2243441-2017-00124 for patient three.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.Additional information was received on 8/24/17 update: it was reported that the tamper tube didn't function on its own and had to be manually tamped.A pre deployment angiogram was performed.Hemostasis was achieved by manual tamponing of the tube.It was reported stable/successful case.The outcome was reported to be successful.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the completed investigation results.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.

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.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: 6865780
• MDR Text Key: 86323173
• Report Number: 2243441-2017-00122
• 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,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?: No
• 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: 11/03/2017
• 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 Age: 72 YR
• Patient Weight: 85