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

Catalog Number	C610134
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device has been returned to the manufacturing facility for evaluation.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.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 two similar reports with the involved product code/lot# combination.The user facility reported similar events from the same product code/lot number combination.See mdrs 2243441-2017-00097 and 2243441-2017-00098.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 physician stated that after setting the anchor when going to pull back on the handle that the tamper tube was not sliding down and that gear started to grind before the green marker was exposed.He felt as if he was pulling to hard so he aborted and held manual pressure assuring hemostasis was achieved.It was reported that the patient condition was stable.It was reported the procedure outcome was successful.Additional information was received in august 6, 2017.There were no other devices were used with the reported product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the evaluation results.One 6fr used angioseal evolution devices was received at terumo medical corporation for product evaluation.The returned device was subjected to visual analysis where a blood like substance was found along the body of the device.No accessory components were returned.The compaction tube was partially exposed, with only the distal marker exposed, from the carrier tube assembly along with a small portion of the carrier tube assembly.The hemostatic sheath was mated with the deployment sleeve, which was in the rear lock positon with the color bands exposed.The deployment sleeve appeared to be loose at a slanted angle and not necessarily properly secured between the two handles of the device.There appeared to be a greater gap between the upper and lower handle that contributed to this.However, the measurement of this gap could not be taken.The collagen and suture were missing from the distal portion of the suture.The handles of the evolution were then separated with a flat head screwdriver to observe the gearbox assembly.The gearbox assembly was not in the complete distal position; there was a noticeable gap between the upper gear plate and the hex holes of the lower handle.The rack had been moved into the distal position with no portion of the rack visible proximal to the gearbox assembly.The rack and gear drive were appropriately mated and could be turned with little resistance experienced as expected.The gearbox assembly appeared to sit higher in the lower gear handle than was observed in a known good device.No turns of suture were remaining on the spool.Due to the positioning of the rack, no gross functional testing could be performed.The complaint could be confirmed for tamping issues based on the location of the gearbox assembly within the handles.A further investigation has been initiated.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.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: 6F ANGIO-SEAL EVOLUTION 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: 6813756
• Report Number: 2243441-2017-00099
• Device Sequence Number: 13486997
• Product Code: MGB
• UDI-Device Identifier: 05415067002839
• UDI-Public: 05415067002839
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,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 Catalogue Number: C610134
• Device Lot Number: 5879848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 09/06/2017; 11/02/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 09/29/2017; 11/16/2017
• 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