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	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was not returned for evaluation.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 did not find any other report with the involved product code/lot# combination.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code has been referenced in the conclusions.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 deployed an angioseal and shut down the femoral artery.It was reported that the physician repaired it endovascularly with a short viabahn stent in the common femoral.The patient is doing very well at present time.It was reported that the procedure outcome has a good ultimate result with improved tibial blood flow to assist in healing of a right heel lesion.It was reported that there was an insignificant amount of blood loss.Additional information was reported on 8/1/2017: the device deployed in a standard fashion, but there was immediate bleeding after deployment suggesting malfunction.Manual pressure was applied to obtain hemostasis.We then transferred her to recovery, but immediately noticed the foot was dusky and pulseless so we brought her back to the angio suite and accessed the contralateral (left side).With up-and-over technique an angio showed complete femoral artery occlusion.With difficulty we crossed it, aspirated any lose thrombus and then ballooned it over a filter wire producing a partial result.We felt it would reocclude despite multiple prolonged inflations and elected to treat it with a single 6 mm x 50 mm viabahn which produced an excellent result and re-established blood flow.The doctor reported he thought the footplate grabbed a plaque and pulled it to the entry site thereby pinching off and occluding the vessel.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide completed investigation.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: 6813839
• Report Number: 3013394970-2017-00293
• Device Sequence Number: 10983135
• Product Code: MGB
• UDI-Device Identifier: 15414734054598
• UDI-Public: 15414734054598
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/23/2017

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: 5920099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 10/12/2017
• 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: 87 YR