MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-25 for CHOLANGIOGRAPHY CATHETER 4F 420404F manufactured by Edwards Lifesciences.
[139967359]
Pt was having a laparoscopic cholecystectomy with grams peritoneal lavage. Prior to giving the surgeon the cholangiogram catheter, the scrub person tried to flush the catheter and it would not flush. Obtained another catheter, and that also would not flush. The third catheter flushed and was handed to the surgeon to utilize.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085139 |
| MDR Report Key | 8452225 |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-03-19 |
| Date Added to Maude | 2019-03-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CHOLANGIOGRAPHY CATHETER |
| Generic Name | CATHETER CHOLANGIOGRAPHY |
| Product Code | GBZ |
| Date Received | 2019-03-25 |
| Model Number | 4F |
| Catalog Number | 420404F |
| Lot Number | 61516401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | IRVINE CA 92814 US 92814 |
| Brand Name | CHOLANGIOGRAPHY CATHETER |
| Generic Name | CATHETER CHOLANGIOGRAPHY |
| Product Code | GBZ |
| Date Received | 2019-03-25 |
| Lot Number | 61524841 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-25 |