MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION GRAFTS ADVANTA VXT W/GDS; PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER

Model Number	22114
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the heparin test before inserting and connecting the blood vessel, heparin leaked out like water droplets from the outside of the middle part of the tube.The surgery was completed it was delayed for about 20 mins., due to the replacement for the same size graft.Patient's condition is currently good.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
Additional information: section d9 & h6 this complaint reports that during the heparin test of an advanta vxt graft (p/n 22114, l/n 499159), heparin leaked out in droplets from the middle of the graft.The procedure was completed with another graft and no additional harm to the patient was reported.The report states that the patient is in good condition.A picture was provided which shows the used graft, however there is no sign of damage in the picture and the leak is not shown.The graft was returned for evaluation.It was disinfected and inspected for damage in the middle of the graft where the leak was reported to be.No holes, tears, or other signs of damage were identified.Water was run through the graft and it was manipulated in an attempt to cause a leak, but no water leaked through the graft.The dhr for lot 499159 and relevant subassemblies were reviewed and no anomalies in manufacturing were found.No ncrs were identified for any of these lots.It was noted in the review that there is no inspection in place to look for defects in the graft body in the finished good procedures.However, a design control quality plan is in place under dd022187 to add a tactile and visual inspection to mp000502 (graft finished assy, cutting and length verification), which will add an inspection step to the graft body of the finished good before the gds tip is added and the graft is packaged.There is no evidence to suggest that manufacturing, equipment, or design are related to the complaint root cause.The ifu provides adequate instructions, warnings and precautions for the use of this device.It instructs the user not to use the device if it is damaged and provides warnings and precautions against a number of possible causes of damage to the graft.It also warns the user not to pre-wet the graft as this may cause damage to the graft or patient.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 2.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.The user did provide a picture and returned the device for evaluation, however the device nonconformance could not be confirmed.The complaint could not be replicated.No evidence was found to suggest that manufacturing, design, or instructions for use were related to this complaint.The root cause is impossible to define.
Event or Problem Description
N/a.

• Brand Name: GRAFTS ADVANTA VXT W/GDS
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM 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: 18467538
• Report Number: 3011175548-2024-00001
• Device Sequence Number: 7066233
• Product Code: DYF
• UDI-Device Identifier: 00650862221145
• UDI-Public: 00650862221145
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K992958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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 Expiration Date: 08/07/2026
• Device Model Number: 22114
• Device Catalogue Number: 22114
• Device Lot Number: 499159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVANTA GRAFT (B)(6).
• Patient Sex: Prefer Not To Disclose