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

Catalog Number	C610134
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has been 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 product code/lot# combination was conducted with no relevant findings.A search of the complaint file did not find any other reports with the involved product code/lot# combination.The user facility reported similar events from the same product code/lot number combination.See mdrs 2243441-2017-00186 and 2243441-2017-00187.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 deployment difficulties with the angio-seal evolution device.The following information was provided by the user facility: the reporter mentioned that physicians are stating the button that releases the suture so that it is visible to cut is malfunctioning.Physicians state that the button does not depress and they have to pull very hard to expose the suture after several attempts at depressing the button.It was reported that hemostasis was obtained.The issue allegedly lies within the button release.It was reported that the patient is stable.The procedure outcome was reported adequate.Additional information was received on 10/11/17.Hemostasis was achieved by the device.The patient was not effected.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One sealed 6fr angioseal evolution device was returned for evaluation.The device was returned inside a sealed header bag with all accessory components.The header bag was damaged upon removal from the shipping container due to excessive force applied when removing the header bag from tape within the header bag.All components were removed from the header bag and inspected for any gross visual anomalies.No anomalies were found.The polyfoil pouch was then opened revealing the unused evolution device.Since the device had not been deployed and the allegation was against the force used to properly press the suture release button, the device was deployed to determine if the suture release button would function properly.A vessel model was used to deploy the device.First, the hemostatic sheath was properly mated with the deployment sleeve in the forward lock position.This exposed the anchor.The deployment sleeve was then moved into the rear lock position exposing the color bands and posting the anchor to the distal tip of the hemostatic sheath.The body of the evolution was then pulled upwards which engaged the auto tamping mechanism.The compaction tube advance with no adverse resistance experienced.Once the green compaction marker could be seen and the collagen was tamped, the suture release button was pressed.The suture subsequently released from the spool.To ensure that there was no suture remained on the spool, the upper handle of the device was removed and the gearbox assembly was inspected.The suture had been completely deployed with no remaining suture found on the spool.There were no gross visual anomalies observed with the gearbox assembly.The complaint could not be confirmed for deployment difficulties as the device deployed as expected and no anomalies were noted in regards to the function of the suture release button.After pressing the suture release button per the ifu the suture released as expected.There were no gross visual anomalies noted with any of the returned components.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.

• Brand Name: 6F ANGIO-SEAL EVOLUTION 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: 6994492
• Report Number: 2243441-2017-00185
• Device Sequence Number: 1548914
• Product Code: MGB
• UDI-Device Identifier: 05415067002839
• UDI-Public: 05415067002839
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: C610134
• Device Lot Number: 5944906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1