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	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
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 section.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.
Event or Problem Description
The user facility reported the tip of the involved angio-seal device was bent.The following information was provided by the user: the angio-seal was bent coming out of the package.The lab did not use the device on patient, they decided to use another.Additional information was received on (b)(6) 2017.Hemostasis was achieved by the second device used.The patient procedure was successful, and hemostasis was achieved.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation.One 6fr angio-seal vip device was received for product evaluation at.The header bag, polyfoil pouch, arteriotomy locator, and hemostatic sheath were received as well.The returned components were subjected to visual analysis where no blood like substance was observed on the device.The arteriotomy locator and hemostatic sheath were properly mated.The polyfoil pouch appeared partially open.The carrier tube assembly was carefully removed from the pouch.The bypass tube was still secured to the carrier tube assembly.There was a noted kink in the carrier tube assembly at the proximal portion of the manufactured slit in the carrier tube assembly.Off axis, forces have been known to lead to kinks in the carrier tube assembly.Off axis, forces may have arisen form the user not opening the polyfoil pouch per the ifu.Ifu 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." 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: 7046522
• Report Number: 3013394970-2017-00539
• Device Sequence Number: 19274856
• Product Code: MGB
• UDI-Device Identifier: 05414734054591
• UDI-Public: 5414734054591
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/20/2017

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: 5890066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 79