MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA SLIDER GDS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	22072
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
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
When opening before surgery, we found foreign substances in the graft packaging and immediately changed it to another graft and had surgery.
Additional Manufacturer Narrative
Additional information section: d8.This complaint reports that an advanta vxt graft (p/n 22072, l/n 480842) was opened and a foreign substance was seen inside.The reporter stated that some of the substance blew away and the remainder of it was taped down to the tray cover.The customer provided a picture which shows two dark spots on the tray cover being held with tape.The device was returned and it was confirmed that there were two dark spots on the underside of the tray cover.A material investigation was completed for the substance.Magnified pictures of the dark spots determined them to be clusters of dark fibers.The samples were analyzed using ftir and micro-atr and the tape was also analyzed without the fibers as a control.Both testing methods determined that the closest match to the fibers is human hair.This material was noticed by the user after the graft tray was opened.Therefore it cannot be known if the hair was introduced before or after the tray was opened.These devices are manufactured and packaged in a clean environment and the presence of hair is procedurally prevented and inspected for so.Additionally, the hair on this device does not appear to be a stray hair that fell out somehow ended up in the packaging.The clusters appear more consistent with hair that was recently cut or shaved.The procedure the device was intended to be used for is not known, however it is often necessary to shave away hair from a surgical location prior to the procedure.The dhr for lot 480842 and relevant incoming inspection were reviewed and no anomalies in manufacturing were found.No ncrs were identified for this lot or for the inner tray lid.There is no evidence to suggest that manufacturing, equipment, or design are related to the complaint root cause.The ifu provides adequate instructions for the use of this device and cautions a user not to use the device if the packaging is damaged.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found no similar complaints.This complaint is confirmed, however it cannot be confirmed that the hair was introduced prior to the tray being opened.The root cause of this complaint is impossible to define.However due to the manufacturing precautions taken to prevent hair from getting into the tray, the appearance of the hair, and the likelihood that the patient would have had some hair shaved prior to the procedure, the most likely cause of this complaint is the introduction of hair during the procedure due to user error.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Correction section: h11.This complaint reports that an advanta vxt graft (p/n 22072, l/n 480842) was opened and a foreign substance was seen inside.The reporter stated that some of the substance blew away and the remainder of it was taped down to the tray cover.The customer provided a picture which shows two dark spots on the tray cover being held with tape.The device was returned and it was confirmed that there were two dark spots on the underside of the tray cover.A material investigation was completed for the substance.Magnified pictures of the dark spots determined them to be clusters of dark fibers.The samples were analyzed using ftir and micro-atr and the tape was also analyzed without the fibers as a control.Both testing methods determined that the closest match to the fibers is human hair.This material was noticed by the user after the graft tray was opened.Therefore it cannot be known if the hair was introduced before or after the tray was opened.These devices are manufactured and packaged in a clean environment and the presence of hair is procedurally prevented and inspected for so.Additionally, the hair on this device does not appear to be a stray hair that fell out somehow ended up in the packaging.The clusters appear more consistent with hair that was recently cut or shaved.The procedure the device was intended to be used for is not known, however it is often necessary to shave away hair from a surgical location prior to the procedure.The dhr for lot 480842 and relevant incoming inspection were reviewed and no anomalies in manufacturing were found.No ncrs were identified for this lot or for the inner tray lid.There is no evidence to suggest that manufacturing, equipment, or design are related to the complaint root cause.The ifu provides adequate instructions for the use of this device and cautions a user not to use the device if the packaging is damaged.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.One excursion was identified for exceeding the 3 standard deviation limit in october 2024, for which (b)(4) was opened.A complaint history review was completed which found no similar complaints.This complaint is confirmed, however it cannot be confirmed that the hair was introduced prior to the tray being opened.The root cause of this complaint is impossible to define.However due to the manufacturing precautions taken to prevent hair from getting into the tray, the appearance of the hair, and the likelihood that the patient would have had some hair shaved prior to the procedure, the most likely cause of this complaint is the introduction of hair during the procedure due to user error.
Event or Problem Description
N/a.

• Brand Name: ADVANTA SLIDER 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: 20507362
• Report Number: 3011175548-2024-000023
• Device Sequence Number: 8390398
• Product Code: DSY
• UDI-Device Identifier: 00650862220728
• UDI-Public: (01)00650862220728(17)250222
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2025

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: 02/22/2025
• Device Model Number: 22072
• Device Catalogue Number: 22072
• Device Lot Number: 480842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 12/06/2024; 02/18/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/11/2024; 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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: UNKNOWN.
• Patient Sex: Male