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 2016-06-01 for ARTEGRAFT AG636 manufactured by Artegraft, Inc..
[46368178]
Artegraft, inc. Performed a review of the batch history records; upon release, the batch met all requirements including pressure test results. To date, no additional complaints were reported from the same product batch and no complaints for the same issue of "broken graft during tunneling" were received in the past 2 years. It is unknown if procedural issues contributed to the reported event. Upon completion of evaluation of the returned product, a follow-up report will be submitted. The complaint issue will continue to be monitored within artegraft, inc. Quality systems, quality assurance trending.
Patient Sequence No: 1, Text Type: N, H10
[46368179]
An approved distributor reported on behalf of the vascular surgeon that during the tunneling procedure of graft implantation, the artegraft (collagen vascular graft) "broke". The surgery was able to be completed using a second artegraft device. Details of the procedure were requested by artegraft; however, to date were not provided.
Patient Sequence No: 1, Text Type: D, B5
[54710361]
Evaluation of the returned vascular graft (15d103-017) was performed. The vascular graft was returned to artegraft, inc. Not in its original packaging and without liquid storage solution, which may have affected the consistency of the graft. Possible root causes for the graft being torn may be due to excessive external forces, such as the type of tunneling device, size of needle, and amount of pressure applied. Per the artegraft website faq (http://artegraft. Com/products/faqs), it is not recommended that artegraft be inserted and pulled through the lumen of a tunneling device. Information on type of tunneler, technique, and needle size were requested from the customer but was not provided to artegraft. To date, no additional complaints were reported for this issue of "broken graft during tunneling" and no complaints were reported from the same product batch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247686-2016-00007 |
| MDR Report Key | 5692931 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-06-01 |
| Date of Report | 2016-05-03 |
| Date of Event | 2016-05-02 |
| Date Mfgr Received | 2016-08-09 |
| Device Manufacturer Date | 2015-06-04 |
| Date Added to Maude | 2016-06-01 |
| 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 | 2016-06-01 |
| Returned To Mfg | 2016-05-12 |
| Model Number | AG636 |
| Catalog Number | AG636 |
| Lot Number | 15D103-017 |
| Device Expiration Date | 2018-05-31 |
| Operator | PHYSICIAN |
| 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 | 2016-06-01 |