MalfunctionDQD
BARD
Received Aug 26, 2004 · Event occurred Aug 16, 2004
Report MW1033092 · MDR key 554395
Device
Generic name
Groshong Catheter 8 Fr.
Manufacturer
Bard Acess SystemsModel number
*Catalog number
0603590
Lot number
22E04518
Product problems
- Fracture
- Migration or Expulsion of Device
- Device, removal of (non-implant)
Patient
51 YR
- Surgical procedure
Narrative
Description of Event or Problem
IN 7/26/2004 PT HAD GROSHONG/MRI PORT INSERTION FOR BREAST CANCER-CHEST X-RAY SHOWED TIP IN RIGHT ATRIUM. PT RETURNED TO SURGERY AFTER ONE MONTH BECAUSE OF PORT MALFUNCTION. CATHETER WAS REMOVED, AND IT WAS NOTED THAT THERE WAS A FRACTURE OF CATHETER AT THE LEVEL WHERE THE CATHETER PASSED OVER THE CLAVICLE WITH MIGRATION OF THE CATHETER.