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 2018-10-22 for ARTEGRAFT AG740 manufactured by Artegraft, Inc..
[126229248]
Return of the complaint graft has been requested by artegraft, inc. For evaluation. The complaint artegraft (collagen vascular graft) lot number 17m381-020 has not yet been returned for further evaluation. Several attempts have been made to obtain the graft. Should the graft be returned, or additional information become available, a follow-up report will be submitted. No adverse events to the patient were reported. A review of the device history record was performed; no abnormalities were identified. All grafts released from batch 17m381 passed the requirements for release, including: wall thickness, pressure testing, and final visual inspection prior to release to finished goods. No directly related non-conformnaces were identified to the leaking graft complaint. To date, no additional complaints from the batch have been reported. The complaint issue will continue to be monitored within artegraft, inc. Quality assurance trending.
Patient Sequence No: 1, Text Type: N, H10
[126229249]
Artegraft, inc. Received an electronic implant usage card with a note stating "graft is defective and will be picked up by vendor for evaluation". Additional information was received from an approved distributor representative on behalf of a vascular surgeon (dr. (b)(6)) explaining that the graft had leaked during the pre-implant pressure test per the corresponding artegraft, inc. Ifu. The surgeon did not implant the graft (17m381-020). No patient adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2018-00007 |
| MDR Report Key | 7990809 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-10-22 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2018-10-25 |
| Device Manufacturer Date | 2018-02-20 |
| Date Added to Maude | 2018-10-22 |
| 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 | 2018-10-22 |
| Returned To Mfg | 2018-10-25 |
| Model Number | AG740 |
| Catalog Number | AG740 |
| Lot Number | 17M381-020 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-22 |