MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION GRAFTS FLIXENE GRAFTS W/GDS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	25142
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
The surgery was for hepatitis patient for implanting ptfe graft.For two pieces of our flixene they faced the same issue that the gds wasn't fixed firmly and it was disconnected from the graft there was no involvement for the patient, since the incident happened prior to insertion.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Investigation summary: the surgery was for a patient with end stage renal disease for creating a hemodialysis access site in the lower limb.The patient is reported to have hepatitis.For two pieces of our flixene they faced the same issue that the gds wasn't fixed firmly and it was disconnected from the graft just after opening the package during an attempt to connect the gds to the tunneler rod.Details of the two pieces are: - product /1/: flixene vascular graft - ref.25142 - sn.(b)(6).Ln 502151.- product /2/: flixene vascular graft - ref.25142 - sn.(b)(6).Ln 502151.The defective items are not available for investigation due to the contamination (hepatitis).There was no involvement for the patient, since the incident happened prior to insertion (during an attempt to attach the gds to the tunneler rod).After the first device separated, a second device was obtained but exhibited the same separation issue.Long forceps were used instead of the tunneler rod/gds to tunnel the graft.This caused a 10-15 minute delay to the procedure.A review of the video provided was conducted and it is clear that the gds swivel rod has separated from the swivel core prior to the product being tunneled confirming both the complaints associated with this procedure (979494 and 979919) and a device nonconformity.The complaint history review identified three other complaints where the swivel rod separated from the swivel core.However, the root causes either have not yet been determined or was impossible to define.There were also three complaints identified where the gds was reported to have a large gap between the components but was not separated.The investigation for these complaints found the root cause to be related to the manufacturing assembly process with a contributing factor of design.The equipment used to crimp the swivel rod onto the swivel core was found to be out of specification, resulting in the inadequate crimp.The ncr investigations concluded that machine is found to be the most probable root cause for this non-conformance.Investigations performed proved that loose faceplate leads to poor crimping.The reason for having a loose faceplate could be due to stud slippage over time due to machine vibrations and wear.It was also found one of the original studs of the equipment to be sheared to a shorter length.Additionally, method is a contributor for this ncr as the inspections in place are not adequate to catch a nonconformance under typical use in the field.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.The investigation has concluded that the product in question was possibly not assembled properly based on the separation of the swivel rod from the swivel core and is related to the gds crimping equipment discrepancies found in previous investigations.A capa and health hazard evaluation (hhe) are ongoing.H3 other text : device not available for return.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Related mfg report # 3011175548-2024-00066 additional information: sections a2, a3, a4, b7, h6.

• Brand Name: GRAFTS FLIXENE GRAFTS W/GDS
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 18728059
• Report Number: 3011175548-2024-00065
• Device Sequence Number: 12248302
• Product Code: DSY
• UDI-Device Identifier: 00650862251425
• UDI-Public: 00650862251425
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2024

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 Model Number: 25142
• Device Catalogue Number: 25142
• Device Lot Number: 502151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 02/28/2024; 03/20/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 02/28/2024; 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 95 KG