FDA Adverse Event
Malfunction
Summary report: N
DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM
MDR report key: 3170059
·
Received June 14, 2013
Report
- Report Number
- 2021898-2013-00211
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 6, 2013
- Report Date
- May 21, 2013
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K042465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE TIP OF THE CATHETER PASSER BROKE WHEN THE PHYSICIAN WAS USING THE DEVICE. IT WAS ALSO REPORTED THAT THE PHYSICIAN COULD NOT FIND THE BROKEN PIECE WHEN THEY WENT TO RETRIEVE IT OUT OF THE PATIENT. THE PATIENT WAS REPORTED TO BE OK AND STILL UNDER OBSERVATION AT THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271832 | DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | D36270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR |