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	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned to the manufacturing facility 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 found one similar report with the involved product code/lot# combination.The user facility reported similar events from the same product code/lot number combination.See mdrs 3013394970-2017-00336 and 3013394970-2017-00338.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 the angioseal was prepped per ifu and upon advancing device over.035" wire, it was noticed that there was a kink in the entry sheath.It was reported that the patient condition was stable.It was reported that the procedure outcome was successful.Additional information was received on 8/15/2017: the blood loss was not greater than 250cc.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation.A used 6 fr angio-seal vip arteriotomy locator and sheath was returned for product analysis.No additional components were returned.The sample was subjected to visual analysis where a blood like substance was found along the hemostatic sheath and arteriotomy locator.The hemostatic sheath was mated with an arteriotomy locator.A bulge in the hemostatic sheath material was observed at the blood inlet holes approximately 0.5815" from the distal tip of the hemostatic sheath.The arteriotomy locator was then removed from the hemostatic sheath and a bend at the blood inlet hole was observed.The complaint could be confirmed for a kink at the blood inlet holes on the second device.However, the blood inlet holes act as a stress concentrator in the material and when sufficient compressive force is applied to the hemostatic sheath and arteriotomy locator, deformation is known to occur at this point.It is likely the opposing forces may stem from the user applying excessive force to overcome the resistance felt as the assembly was inserted inot the patient.This is likely not a manufacturing issue since the arteriotomy locator and hemostatic sheaths are 100% inspection during the packaging of the device.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 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: 6839473
• Report Number: 3013394970-2017-00337
• Device Sequence Number: 800864
• Product Code: MGB
• UDI-Device Identifier: 05414734054591
• UDI-Public: 05414734054591
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

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: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 610130
• Device Lot Number: 5916391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1