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 Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	09/06/2017
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.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 user facility reported similar events from the same product code/lot number combination.See mdr 3013394970-2017-00407.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 device collagen remained outside the body and had to be put under the skin.It was reported that the end of the deployment sheath was crimped upon removal.It was reported that the patient condition was good.It was reported that the procedure outcome was good.Additional information was received on 9/8/17: it was reported that hemostasis was achieved by holding pressure.When they first tried to tuck the collagen under the skin it began bleeding.Pressure was held, and then they tucked the collagen under after hemostasis had been achieved.The amount of blood loss is unknown.It was reported that the patient condition was stable.When the device was removed from the package, they noticed the distal tip damage.A new device was opened.An 8fr sheath was used.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the returned sample evaluation results.One 8f angioseal vip was returned for evaluation.One carrier tube assembly was returned mated with the hemostasis sheath.The plastic pouch was also returned.The carrier tube hub was returned in full rear lock position.There was no tamper tube returned and the suture was cut manually some distance from the tip of the monofold.The end of the suture was inspected under magnification and it appeared to be cut manually with a blade.The device was disassembled and the tensioner frame was inspected.There was blood like substance observed over the hub but there was no wound suture remaining within the spool.No anomalies were noted.The device was returned in the state of full deployment.Angioseal vip instructions for use (angioseal vip ifu art100041662 d (2016-01)) were reviewed and the following instructions were found relevant: "very thin patients - collagen may protrude from the skin after tamping has been completed.Attempt to push the collagen under the skin using the tamper tube or a sterile hemostat.Do not apply vigorous tamping as this may result in anchor fracture.Do not cut off the excess collagen, as the suture woven through the collagen may be cut and the integrity of the anchor/collagen sandwich could be compromised." in absence of information such as patient anatomy, vascular health, drug regiment and other patient demographics, exact determination cannot be made for the cause of this event but it is likely that the patient was thin and had less than average subcutaneous tissue and fat.The ifu considers this situation and adequately explains the procedure to be followed in the case of collagen protruding outside artery.The device was evaluated and no anomalies could be found.The device was returned in a state of complete deployment.In absence of information such as patient anatomy, vascular health, drug regiment and other patient demographics, exact determination cannot be made for the cause of this event but it is likely that the patient was thin and had less than average subcutaneous tissue and fat.The ifu considers this situation and adequately explains the procedure to be followed in the case of collagen protruding outside artery.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.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 results.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: 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: 6910901
• Report Number: 3013394970-2017-00406
• Device Sequence Number: 108323
• Product Code: MGB
• UDI-Device Identifier: 05415067002853
• UDI-Public: 05415067002853
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2017

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: 610131
• Device Lot Number: 5883393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 10/05/2017; 11/06/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 11/01/2017; 11/22/2017
• 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: Other; Required Intervention