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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was not returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, (b)(4) has been referenced in the conclusions section of evaluation codes.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 found one similar report with the involved product code/lot# combination.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 they used an angio-seal evolution 6fr to perform a diagnostic angiography procedure in the cath lab.The following information was provided by the user facility: during the closure of the puncture and after the doctors deploy the anchor, the doctor pulled the device handle into full rear position and the sleeve snap locked.When the doctor pressed the suture release button and pullback, the suture cable broke.Hemostasis was achieved with manual pressure.It was reported that there was no surgical intervention required, no complications, and no infectious disease reported.Patient observation during the following hours.Femoral introducer and regular guide wire were used with the reported product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation.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
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 2101 cottontail ln.; somerset NJ 08873
• MDR Report Key: 6849247
• Report Number: 2243441-2017-00116
• Device Sequence Number: 11120468
• Product Code: MGB
• UDI-Device Identifier: 05415067002839
• UDI-Public: 05415067002839
• Combination Product (Y/N): N
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2017

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: 01/31/2018
• Device Catalogue Number: C610134
• Device Lot Number: 5871767
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 10/16/2017
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 91