MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-25 for QUINTON PERMACATH UNKNOWN manufactured by Quinton Instrument Company.
[9968]
On 6/30/93, a double lumen permacath was inserted in patient's right internal jugular and passed to the superior vena cava (svc). On 7/12, patient was seen by her physician because the catheter looked "longer" and the dacron cuff was approximately 5 inches outside of the "exit site. " on 7/13, the patient was admitted to the user facility via the emergency room. Chest x-ray revealed extravasation of contrast media at the level of mid-svc into mediastinum. Site of extravasation is adjacent to distal tip of catheter, suggesting that the catheter tip may be eroding the wall of svc. The plan was to remove the catheter, but it fell out on its own. The erosion site of the svc apparently sealed off on its own. No other intervention was required other than obtaining a new access for dialysis. Addendum: the physician who inserted the permacath, placed the catheter so that the dacron cuff was underneath the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16351 |
| MDR Report Key | 16351 |
| Date Received | 1994-01-25 |
| Date of Report | 1993-07-26 |
| Date of Event | 1993-07-13 |
| Date Facility Aware | 1993-07-13 |
| Report Date | 1993-07-26 |
| Date Reported to Mfgr | 1993-07-27 |
| Date Added to Maude | 1994-09-23 |
| 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 | 0 |
| 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 | QUINTON PERMACATH |
| Generic Name | CATHETER ACCESS FOR DIALYSIS |
| Product Code | FGH |
| Date Received | 1994-01-25 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 13 DAY |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16284 |
| Manufacturer | QUINTON INSTRUMENT COMPANY |
| Manufacturer Address | 2121 TERRY AVENUE SEATTLE WA 98121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 1994-01-25 |