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	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier - unknown.Age & date of birth - appeared around 65, date of birth was unknown.Weight - appeared around 180.Ethnicity - not provided.Race - not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned, therefore an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that an experienced user of angioseal evolution deployed the device.The anchor appeared to be deployed, but the compaction tube did not advance.The following information was provided by the user facility: this resulted in the doctor not being able to see the green marking to know when to stop pulling.The doctor pulled additionally 3 times with the patient and still saw no compaction tube advance.Patient was in pain, but appeared to be ok.The doctor was extremely concerned that the anchor may have traveled down the leg.It was reported that the procedure outcome appeared to be successful.For closure they held pressure as oozing was still present.Additional information was received on 11/17/2017: it was reported that the patient did not have surgery to remove the displaced anchor.Whether or not it moved, the facility can't confirm.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information.The actual device was not returned to the manufacturing facility for evaluation.The investigation is currently re-opened and ongoing.A follow up report will be submitted once the investigation is complete.
Event or Problem Description
Additional information was received on december 8, 2017: it was reported that hemostasis was not achieved with the angioseal.They were able to hold pressure and the patient successfully stopped bleeding post-op.No further complications were reported.It was confirmed that they physically saw the sample and that the anchor is still in the angioseal sheath.Therefore, it was not left in the patient.It was reported that the collagen was not tamped down and deployed due to not existing the sheath upon application.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide that the additional information provided on follow up 1 didn't change the investigation results that were on the initial report.

• 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: 7071154
• Report Number: 2243441-2017-00217
• Device Sequence Number: 685226
• Product Code: MGB
• UDI-Device Identifier: 05415067002839
• UDI-Public: 05415067002839
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/30/2017

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 Catalogue Number: C610134
• Device Lot Number: 5879848
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 12/08/2017; 01/05/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 01/05/2018; 01/11/2018
• 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: Required Intervention