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

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 (b)(4) other report with the involved product code/lot# combination.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.
Event or Problem Description
The user facility reported pull out with the involved angio-seal device.The following information was provided by the user facility: the doctor did everything right as far as the steps go to load the device.; upon pulling back, he met no resistance against the vessel wall; after he pulled back, there was no anchor, collagen, suture, or tamper; they held manual pressure, and there were no complications; the patient was reported to be in stable condition; and there were no other devices or equipment used with the reported product.

• Brand Name: 6F ANGIO-SEAL VIP 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: 6976286
• Report Number: 3013394970-2017-00457
• Device Sequence Number: 1130279
• Product Code: MGB
• UDI-Device Identifier: 05414734054591
• UDI-Public: 05414734054591
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 10/25/2017

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: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 610130
• Device Lot Number: 6020857
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/25/2017
• 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: 73 YR