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	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2017
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 did not find any other report with the involved product code/lot# combination.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 angio-seal pulled apart after the first click.It was reported that they were still able to set the footplate and suture down collagen.It was reported that the patient condition was not affected.They were awake, alert and orientated.It was reported that the procedure outcome was not affected and had a successful closure.It was reported that the blood loss was less than 250cc's.There were no other products used with the reported device.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One used 6fr angioseal vip device was received for evaluation.The device was returned with the hemostatic sheath, arteriotomy locator, and guidewire.The returned components were subjected to visual analysis where a blood like substance was covering the device.The guidewire was successfully mated with the arteriotomy locator.The hemostatic sheath was not mated with the deployment sleeve, which was in the rear lock position.Instead, the hemostatic sheath was detached from the angioseal device where the bypass tube was inserted into the hemostatic sheath.There was a shallow bend in the carrier tube assembly.The tamping tube was completely removed from the carrier tube assembly.Additionally a portion of the suture was separated from the carrier tube assembly.The remaining portion of the suture was in the carrier tube assembly.The distal portion of the suture in the carrier tube assembly was caught in the manufactured slit.Force was applied to the suture in the carrier tube assembly and the additional suture was released from the spool.The complaint could be confirmed for detached/separated.The defect category will be updated accordingly.Analysis of the "slit" revealed that the customer's concern was the manufactured slit in the carrier tube assembly.There was no additional slit or fracture present with the returned device.There were signs however that an attempt had been made to assemble the hemostatic sheath and deployment sleeve.However, from the returned device it does not appear as though this attempt secured the deployment sleeve in the hemostatic sheath.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: 6846108
• Report Number: 3013394970-2017-00341
• Device Sequence Number: 65781
• Product Code: MGB
• UDI-Device Identifier: 05414734054591
• UDI-Public: 05414734054591
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 09/06/2017

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: 5896170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 115