MAUDE Adverse Event Report: ARTEGRAFT, INC ARTEGRAFT; COLLAGEN VASCULAR GRAFT

Device Problems Inadequate or Insufficient Training (1643); Facilities Issue (2935)

Patient Problem No Code Available (3191)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

A photograph of the "demo" artegraft product tube was provided for evaluation.The tube was labeled with large clear wording along the entire length as "product for demonstration and training purposes only", "non sterile, not for use in or on human subjects".Artegraft, inc.Verified that the graft from the empty set-up box (15k278-008) was implanted by dr.(b)(6) medical center in (b)(6) 2016.A quality control issue was identified at the hospital.Artegraft, inc.Informed the hospital to destroy any additional full length artegraft product labeled as "demo" that they may have in their possession.

Event Description

Artegraft received a phone call from (b)(6) medical center to report that during a surgical procedure, the vascular surgeon, dr.(b)(6) had unintentionally implanted an artegraft "demo" sample graft that was labeled as such.In follow-up reports, it was explained that someone at the hospital placed the "demo" sample graft inside of an empty artegraft set-up box (labeled lot # 15k278-008) and placed the box back into inventory.It was explained that someone at the hospital removed the "demo" sample graft from the hospital inventory and prepared the graft "like normal" without realizing it was labeled as "demo" until after the surgeon had implanted the graft.The patient was not 'closed up' yet when it was identified that the implanted artegraft product tube was labeled as "non-sterile", "not for use in or on human subjects".The "demo" artegraft was explanted and another sterile artegraft was implanted (lot not provided) during the same procedure.The patient was treated for possible infection.The explanted "demo" sample graft was destroyed per hospital regulations.The patient remained in the hospital for 2 days following the procedure to be monitored prior to release; it was reported that the patient was released and is "doing great".

Manufacturer Narrative

Artegraft, inc.Received a response from the implanting vascular surgeon dr.(b)(6).Additional information was provided.The location of the implant was in the patient's right upper arm.On follow-up in the surgeon's office about a week later, the patient did not have any evidence of infection with his graft.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer (Section G): ARTEGRAFT, INC; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer Contact: cynthia salter ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 6802135
• MDR Text Key: 82962716
• Report Number: 2247686-2017-00007
• Device Sequence Number: 1
• Product Code: LXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention