N
Patient 1
(B)(4). MANUFACTURING SITE EVALUATION: NO DEVICE WAS RETURNED: AN EVALUATION WAS NOT PERFORMED. IF ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
MAUDE MDR 8340206
- MDR report key
- 8340206
- Report number
- 9610612-2019-00047
- Event key
- 0
- Event type
- 3
- Date received
- 2019-02-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. NICOLE BROYLES
- Address
- 615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
- Phone
- 314-314-3145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TUNNELING INSTRUMENT 600MM | HYDROCEPHALUS VALVES | AESCULAP AG | HAO | FV004R | FV004R | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-14 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS AN INTRAOPERATIVE ISSUE WITH THE TUNNELING INSTRUMENT AND PROGAV INSERTION. THE HANDLE WINGS BROKE DURING USE IN A HYDROCEPHALUS VALVE/SHUNT PLACEMENT PROCEDURE ON A PATIENT WITH NORMAL PRESSURE HYDROCEPHALUS (NPH). THE TUNNELING INSTRUMENT WAS BEING USED TO ATTEMPT TO ACCESS THE ABDOMEN (GOING BEHIND THE EAR TO THE ABDOMEN WITHOUT A RELEASE CUT). THE SURGEON WAS NOTED AS PULLING WITH ENORMOUS POWER WHEN BOTH HANDLE WINGS BROKE AND THEN A SMALL PIECE OF A HANDLE REMAINED AT THE TROCAR. NEVERTHELESS, THE SURGEON PULLED THROUGH THE PERITONEAL CATHETER; HOWEVER, THE CATHETER WAS DAMAGED AND REMOVED AND A DIFFERENT PROGAV WAS OPENED AND IMPLANTED. THERE WAS A DELAY OF ABOUT 30 MINUTES IN THE OPERATION BUT NO HARM TO THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION IS NOT AVAILABLE.