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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device has been returned 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 findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.
Event or Problem Description
The user facility reported that the physician attempted to deploy the footplate and the device was kinked and would not advance through the arteriotomy locator.The physician then did manual pressure.Nothing was deployed in the patient with regard to the angioseal device.The patient was reported to be fine.The procedure outcome was reported to be fine.
Additional Manufacturer Narrative
One used 6fr angioseal vip device was returned for evaluation.Returned with the carrier tube assembly were the hemostatic sheath and a partially opened polyfoil pouch.No other accessory components have been returned.The returned device was subjected to visual analysis where blood like substance was found on all returned components.The collagen could be seen protruding from the hemostatic valve.Only a portion of the collagen appeared to have been exposed to blood like substance as evident by the coloring of the collagen.The deployment sleeve was not properly mated with the hemostatic sheath.Approximately 1.25" of the tamping tube could be seen extended from the carrier tube assembly.The deployment sleeve was in the rear lock position with the color bands fully exposed.The bypass tube was found along the length of the carrier tube assembly below the deployment sleeve.There was a kink in the carrier tube approximately 5" from the distal tip of the carrier tube assembly.The complaint could be confirmed for a kink in the carrier tube assembly.No conclusion can be drawn as to the cause of the kink that was observed, however it is known that off axis forces can cause kinks.Off axis, forces may have arisen during the insertion of the carrier tube into the hemostatic sheath.Ifu(arten600006628 rev.A) states "under strict sterile conditions and using a sterile field, remove the angioseal device contents from the foil package taking care to pull foil part completely before removing the angioseal device." and "confirm that the device sleeve has remained in the rear holding position.Carefully grasp the angioseal device at the bypass tube in the palm of the hand and with the reference indicator facing up slowly insert the bypass tube and the carrier tube in to the insertion sheath hemostatic valve." 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.

• 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: 7037110
• Report Number: 3013394970-2017-00533
• Device Sequence Number: 19109820
• Product Code: MGB
• UDI-Device Identifier: 15414734054598
• UDI-Public: 15414734054598
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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 Model Number: N/A
• Device Catalogue Number: 610130
• Device Lot Number: 5920105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/19/2017
• 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