MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Model Number	N/A
Medical Device Problem Codes	Kinked (1339); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has been returned to the manufacturing facility for evaluation.One 8fr angio-seal vip device was returned evaluation.The hemostasis sheath was returned along with the packaged carrier tube assembly, the arteriotomy locator, and the guidewire.There was no damage or deformation noted upon visual inspection.The alleged 'pinched end' is, in fact, a manufacturing feature termed as the monofold which enables correct release of the anchor within the vessel.The carrier tube assembly was opened and inserted into the hemostasis sheath and anchor was posted an intended.The deployment was completed by manually pulling the anchor and allowing the autotamp action to complete.The device deployed as intended.The complaint cannot be confirmed.There were no anomalies or deformation noted on the device.It is likely that the customer mistook the monofold feature as a deformity.A review of the device history record of the product code/lot# combination was conducted with no findings.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.
Event or Problem Description
The user facility reported that the tip of the sheath component of the angio-seal was pinched on the facing end of the outer sheath component.The doctor did not want to use the product and asked for a new angio-seal.Hemostasis was achieved with a different angio-seal device.The patient and the procedure outcome was fine.

• Brand Name: 8F 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: 7418689
• Report Number: 3013394970-2018-00157
• Device Sequence Number: 13814587
• Product Code: MGB
• UDI-Device Identifier: 05415067002853
• UDI-Public: 05415067002853
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/10/2018

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: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 610131
• Device Lot Number: 5914476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1