MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2017-10-17 for ARTEGRAFT AG730 manufactured by Artegraft, Inc.
[90441058]
The complaint artegraft (collagen vascular graft) lot 17a008-009 was not returned to artegraft, inc. For evaluation as it was repaired and implanted. The patient was reported to be in stable condition. A review of the production batch device history record was performed; no anomalies were identified. All grafts released from product batch 17a008 passed all of the requirements including pressure testing prior to final release to finished goods. The customer's allegation of leaking graft pre-implant was not able to be confirmed as the graft remains implanted. As this is a known issue, artegraft, inc. Instructions for use include instructions for pressure testing each graft prior to implant. This step was correctly completed by the implanting surgeon. To date, no additional complaints were reported from this product batch. 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.
Patient Sequence No: 1, Text Type: N, H10
[90441059]
Artegraft inc. Received an email communication from an authorized distributor that an artegraft (collagen vascular graft) was identified as leaking during the pre-implant pressure testing per the corresponding artegraft ifu. The surgeon noted that the graft appeared to have a small 1 mm hole in it and was leaking in the middle of the graft, not near a branch. The surgeon was able to repair the graft hole with 6. 0 prolene suture and the graft (lot: 17a008-009) was successfully implanted. No patient adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2017-00009 |
| MDR Report Key | 6955649 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2017-09-29 |
| Device Manufacturer Date | 2017-02-21 |
| Date Added to Maude | 2017-10-17 |
| 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 | 2017-10-17 |
| Model Number | AG730 |
| Catalog Number | AG730 |
| Lot Number | 17A008-009 |
| 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 | 2017-10-17 |