MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-27 for CSF-VENTRICULAR PORT, 16MM SIDE INLET CONNECTOR 44010 manufactured by Medtronic Neurosurgery.
[58919616]
The returned port met the requirements for leak testing. There was proteinaceous debris observed within the interior and exterior of the valve. The returned catheter was patent and met the requirements for leak testing and there was no crack observed on the proximal end of the catheter. Therefore the conditions of the complaint could not be duplicated by laboratory personnel. A review of the manufacturing records showed no anomalies. All ports and catheters are 100% inspected at the time of manufacture. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[58919617]
It was reported to medtronic neurosurgery that the device was found to be cracked preoperatively. According to the report the doctor used a new device to complete the surgery. Reportedly, there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[59596108]
The returned port met the requirements for leak testing. There was proteinaceous debris observed within the interior and exterior of the valve. The returned catheter was patent and met the requirements for leak testing and there was no crack observed on the proximal end of the catheter. Therefore the conditions of the complaint could not be duplicated by laboratory personnel. A review of the manufacturing records showed no anomalies. All ports and catheters are 100% inspected at the time of manufacture. Additional patient/device information: the patient's weight has been provided. It was reported that the patient is currently doing well. It was also later reported that there was no crack found to be on the ventricular catheter.
Patient Sequence No: 1, Text Type: N, H10
[95160687]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2016-00393 |
| MDR Report Key | 6060833 |
| Date Received | 2016-10-27 |
| Date of Report | 2016-09-27 |
| Date of Event | 2016-09-27 |
| Date Mfgr Received | 2016-11-06 |
| Device Manufacturer Date | 2015-12-15 |
| Date Added to Maude | 2016-10-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | BOB SHOKOOHI |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718725 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CSF-VENTRICULAR PORT, 16MM SIDE INLET CONNECTOR |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
| Product Code | LKG |
| Date Received | 2016-10-27 |
| Returned To Mfg | 2016-10-17 |
| Catalog Number | 44010 |
| Lot Number | E05897 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-27 |