MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-08-17 for ARTEGRAFT manufactured by Artegraft, Inc.
[82962716]
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.
Patient Sequence No: 1, Text Type: N, H10
[82962717]
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".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2017-00007 |
| MDR Report Key | 6802135 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-07-21 |
| Date Mfgr Received | 2017-07-21 |
| Date Added to Maude | 2017-08-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CYNTHIA SALTER |
| Manufacturer Street | 206 NORTH CENTER DRIVE |
| Manufacturer City | NORTH BRUNSWICK NJ 089024247 |
| Manufacturer Country | US |
| Manufacturer Postal | 089024247 |
| Manufacturer Phone | 7324228333 |
| Manufacturer G1 | ARTEGRAFT, INC |
| Manufacturer Street | 206 NORTH CENTER DRIVE |
| Manufacturer City | NORTH BRUNSWICK NJ 089024247 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 089024247 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTEGRAFT |
| Generic Name | COLLAGEN VASCULAR GRAFT |
| Product Code | LXA |
| Date Received | 2017-08-17 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTEGRAFT, INC |
| Manufacturer Address | 206 NORTH CENTER DRIVE NORTH BRUNSWICK NJ 089024247 US 089024247 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-08-17 |