MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-04-08 for ARTEGRAFT AG740 manufactured by Artegraft, Inc..
[42195076]
Batch record review of 15f167 was performed; the batch met all criteria, including pressure testing, sterility testing, and final visual inspection upon release. As the graft (b)(4) was not able to be returned for investigation, the complaint regarding the graft leak was not able to be confirmed. Capa-(b)(4) was previously initiated for further investigation. Conclusions are not yet available; pending completion, the results will be kept on file. The complaint issue will continue to be monitored within artegraft, inc. Quality systems, quality assurance trending. Should additional information become available, a follow-up report will be submitted. Graft remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[42195077]
Artegraft, inc. Received a phone call from an authorized distribution center regarding an incident of a leaking artegraft (collagen vascular graft). Upon follow-up discussions with the hospital's sales representative, it was stated that the leak (which appeared to be a tributary) was identified during the pre-implant pressure testing; a suture was used by the surgeon to seal the leak. "the surgeon was confident after repairing the leak to proceed with implanting graft. " no adverse events were reported and the status of the patient was reported as "all is ok".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2016-00003 |
| MDR Report Key | 5563551 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-04-08 |
| Date of Report | 2016-03-11 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2016-03-11 |
| Device Manufacturer Date | 2015-08-05 |
| Date Added to Maude | 2016-04-08 |
| 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 | 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 | 2016-04-08 |
| Model Number | AG740 |
| Catalog Number | AG740 |
| Lot Number | 15F167-014 |
| Device Expiration Date | 2018-07-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2016-04-08 |