MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-17 for QUINTON REF #17749-001 DUAL LUMAN PERM CATH manufactured by Quinton Instrument Co.
[62277]
Pt was sent to the hosp for acute renal failure. Underwent a perm catheter insertion on 6/10/97 for start of dialysis. Under local anesthetic, the right internal jugular vein was accessed. 4 12 french dialator was placed into superior vena cava and then a 14 french peel-away sheath was placed, followed by the dialysis catheter. Some difficulty was encountered with removal of the peel-way sheath. Follow up chest xray noted a small segment of the sheath was seen in the the soft tissue at the neck and right internal jugular vein. On 6/12/97 pt had the retained piece manipulated to the right femoral artery where it was removed via venous cut down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 99260 |
| MDR Report Key | 99260 |
| Date Received | 1997-06-17 |
| Date of Report | 1997-06-12 |
| Date of Event | 1997-06-10 |
| Date Facility Aware | 1997-06-12 |
| Report Date | 1997-06-16 |
| Date Reported to FDA | 1997-06-16 |
| Date Reported to Mfgr | 1997-06-16 |
| Date Added to Maude | 1997-06-23 |
| 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 |
| 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 |
| Generic Name | DIALYSIS CATHETER |
| Product Code | LFK |
| Date Received | 1997-06-17 |
| Model Number | REF #17749-001 |
| Catalog Number | DUAL LUMAN PERM CATH |
| Lot Number | 800789-1997 03 |
| ID Number | 40 CM LENGTH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 97811 |
| Manufacturer | QUINTON INSTRUMENT CO |
| Manufacturer Address | * BOTHELL WA 98021 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-06-17 |