MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-08-29 for ADVANCED VENOUS ACCESS CATHETER M3L9FHKI NA manufactured by Edwards Lifesciences.
[681119]
It was reported that the ava high flow sheath was in place when fluid and air came from the sideport, when fluid was pushed thought the distal port. A second sheath and swan-ganz catheter was placed.
Patient Sequence No: 1, Text Type: D, B5
[7813358]
This device has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000002-2007-05330 |
| MDR Report Key | 905295 |
| Report Source | 05,06 |
| Date Received | 2007-08-29 |
| Date of Event | 2007-08-04 |
| Date Facility Aware | 2007-08-04 |
| Report Date | 2007-09-04 |
| Date Mfgr Received | 2007-09-04 |
| Date Added to Maude | 2007-11-26 |
| 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 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JODI TURPIN |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502004 |
| Manufacturer G1 | EDWARDS LIFESCIENCES |
| Manufacturer Street | STATE ROAD 402 KM 1.4 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCED VENOUS ACCESS CATHETER |
| Generic Name | CENTRAL VENOUS CATHETER KIT |
| Product Code | JCY |
| Date Received | 2007-08-29 |
| Model Number | M3L9FHKI |
| Catalog Number | NA |
| Lot Number | 58317008 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 923263 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ANASCO PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-08-29 |