MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-12 for BARDPORT: IMPLANTED PORT 0604550 * manufactured by Bard Access System, Inc..
[17760630]
Pt admitted for anemia/metastatic work up of left breast cancer stage iia. Past medical history include diabetes mellitus, hypertension, high cholesterol, fractured shoulder. Pt had chemoport placed and was discharged home the next day. The pt was readmitted later with sepsis and pneumonia. Chest x-rays revealed that the catheter was dissconnected from the chemoport and migration to pulmonary artery was confirmed. Attempts by interventional radiologist to remove catheter was unsuccessful. The pt was transferred to another facility for removal of catheter by invasive cardiologist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 537877 |
| MDR Report Key | 537877 |
| Date Received | 2004-07-12 |
| Date of Report | 2004-06-25 |
| Date of Event | 2004-04-23 |
| Report Date | 2004-06-25 |
| Date Reported to FDA | 2004-06-25 |
| Date Added to Maude | 2004-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARDPORT: IMPLANTED PORT |
| Generic Name | CHEMOPORT |
| Product Code | DRQ |
| Date Received | 2004-07-12 |
| Model Number | 0604550 |
| Catalog Number | * |
| Lot Number | 22GN5787 |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 527126 |
| Manufacturer | BARD ACCESS SYSTEM, INC. |
| Manufacturer Address | 5425 WEST AMELIA EARHART DR SALT LAKE CITY UT 84116 US |
| Baseline Brand Name | 2001145-MULTI-MODULE JUNC BOX STIM MODULE |
| Baseline Generic Name | 067 |
| Baseline Catalog No | 2001145 |
| Baseline Device Family | 126020067-LABSYSTEM ACCESSORIES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K883152 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-07-12 |