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 2017-03-16 for ARTEGRAFT AG745 manufactured by Artegraft,inc..
[70182559]
The complaint artegraft (collagen vascular graft) lot 15k263-027 was returned to artegraft, inc. For evaluation. The graft inner/outer diameters and length were verified as compared to the dhr release data. The thickness of the graft wall was calculated as 0. 5 mm; this is well within the required acceptable range (0. 25mm - 1. 5mm) for the product. The customer's allegation of leaking graft pre-implant was confirmed; during the investigative pressure testing (per artegraft, inc. Process specification) bubbles were seen coming from a tributary of the graft. Additionally, 4 indents in the graft wall were observed. Possible root causes for the leaking graft may be that a ligation suture on the graft tributary loosened. The 4 indents observed in the graft wall indicate that the graft may have been mishandled during the pre-implant testing; possibly from the clamp that was applied by the surgeon during the pre-implant testing. It is also possible that too much force was applied during the pre-implant pressure test. No additional information is available regarding the tools/methods utilized by the customer for pressure testing for this incident. As this is a known issue, artegraft, inc. Instructions for use include instructions for pressure testing each graft prior to implant. Capa was previously initiated to investigate similar occurrences involving graft wall leaks pre-implant. Additional quarterly analysis of the grafts was implemented for post-sterilization data and trending. This graft was manufactured in 2015, prior to capa closure. 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
[70182561]
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. In follow-up conversations with the rn from the hospital it was explained that the issue was identified during the graft flushing process; one end of the graft was clamped and saline solution was being flushed into the lumen of the graft. While marking the graft with a directional line, the surgeon noticed the graft was leaking mid-length near a side branch. The surgeon did not implant the graft (15k263-027). Another artegraft ag745 was used to complete the surgery without issue. No patient adverse events were reported. The complaint graft was returned to the original sterilization solution in the artegraft product culture tube (without the plastic support rod) and was returned to artegraft inc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2017-00002 |
| MDR Report Key | 6411261 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-03-16 |
| Date of Report | 2017-02-17 |
| Date of Event | 2017-02-17 |
| Date Mfgr Received | 2017-02-17 |
| Device Manufacturer Date | 2015-12-01 |
| Date Added to Maude | 2017-03-16 |
| 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 | 2017-03-16 |
| Returned To Mfg | 2017-03-06 |
| Model Number | AG745 |
| Catalog Number | AG745 |
| Lot Number | 15K263-027 |
| Device Expiration Date | 2018-10-31 |
| 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 | 2017-03-16 |