MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for STANDARD CATHETER SET AL13113002 manufactured by Varian Medical Systems.
[181938857]
An event took place while treating the last fraction (fx3) of a multi-catheter breast implant with 14 catheters. The dummy sequence took place without any errors or faults, and the video camera was zoomed in on the catheters. We visually confirmed that the dummy wire entered the correct catheter each time, which is the typical practice. After the dummy sequence ended, we zoomed out the camera, so we can see and monitor the patient. The treatment took place uneventfully until catheter no. 9, when the patient reported by voice that something touched her. We immediately stopped the treatment and zoomed in. At that time the wire was outside of patient's body hanging over the neck by about 10cm. After entering the room, we inspected catheter no. 9 and it was connected properly, as all the others. Was only after disconnecting the quick connect, that we discovered what happened: the plastic catheter kinked and the wire managed to push through, puncturing the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9785485 |
| MDR Report Key | 9785485 |
| Date Received | 2020-03-04 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-11-27 |
| Report Date | 2020-01-31 |
| Date Reported to FDA | 2020-01-31 |
| Date Reported to Mfgr | 2020-03-04 |
| Date Added to Maude | 2020-03-04 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD CATHETER SET |
| Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED |
| Product Code | JAQ |
| Date Received | 2020-03-04 |
| Model Number | AL13113002 |
| Catalog Number | AL13113002 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | 911 HANSEN WAY PALO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |