MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2002-11-05 for ADVANCED VENOUS ACCESS HIGH FLOW DEVICE M3L9FS NA manufactured by Edwards Lifesciences.
[21248031]
It was reported that a pt experienced hemorrhagic shock during central venous placement of the device at the right internal jugular vein. It was stated that hemostasis during the operation was problematic. The pt had a hemothorax with a3 liter blood loss. No further pt issues were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000002-2002-00423 |
| MDR Report Key | 426954 |
| Report Source | 01,05,06,07 |
| Date Received | 2002-11-05 |
| Date of Report | 2002-10-11 |
| Date of Event | 2002-09-25 |
| Date Facility Aware | 2002-09-25 |
| Report Date | 2002-10-11 |
| Date Mfgr Received | 2002-10-11 |
| Date Added to Maude | 2002-11-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALLISON MEZZANATTO |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502562 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCED VENOUS ACCESS HIGH FLOW DEVICE |
| Generic Name | CENTRAL VENOUS ACCESS DEVICE |
| Product Code | JCY |
| Date Received | 2002-11-05 |
| Model Number | M3L9FS |
| Catalog Number | NA |
| Lot Number | 941LC763 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 415971 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | RD 402 N. KM. 1.4 INDUST PARK ANASCO CA * US |
| Baseline Brand Name | ADVANCED VENOUS ACCESS CATHETER |
| Baseline Generic Name | CENTRAL VENOUS ACCESS CATHETER |
| Baseline Model No | M3L9FS |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K981909 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2002-11-05 |