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 2016-03-22 for ARTEGRAFT AG630 manufactured by Artegraft, Inc..
[40934412]
The investigation of the returned device ((b)(4)) was unable to confirm the complaint allegation of graft wall "leaking" and "thinner than usual" and the inner diameter of the graft met specifications for an ag630 product code. No additional complaints from this batch were reported to date. Batch record review was performed; the batch met all criteria, including pressure testing, sterility testing, and final visual inspection upon release. The patient status was reported as stable. 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
[40934413]
Artegraft inc. Received an email communication from an authorized distributor (who was present with the doctor during the procedure) that an artegraft (collagen vascular graft) was identified as leaking during the pre-implant pressure testing per the corresponding artegraft ifu. Upon follow up communications, the distributor stated that no hole was visible but rather it appeared that the graft wall was "leaking and thinner than usual". It was also stated that when compared side by side, either the graft inner diameter may have been larger, or another graft's inner diameter was "much smaller" than the size on the label (5 mm id). This graft was not implanted. Another artegraft (ag630 product code) was utilized to complete the procedure. The patient is reported to be in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2016-00001 |
| MDR Report Key | 5517739 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-03-22 |
| Date of Report | 2016-02-22 |
| Date of Event | 2016-02-19 |
| Date Mfgr Received | 2016-02-22 |
| Device Manufacturer Date | 2015-04-23 |
| Date Added to Maude | 2016-03-22 |
| 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 | 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 | 2016-03-22 |
| Returned To Mfg | 2016-03-02 |
| Model Number | AG630 |
| Catalog Number | AG630 |
| Lot Number | 15C064-007 |
| Device Expiration Date | 2018-03-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2016-03-22 |