MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-19 for CSF VENTRICULAR PORT, 16 MM, SIDE INLET 44010 manufactured by Medtronic Neurosurgery.
[114802718]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[114802719]
It was reported that on (b)(6) 2018, the patient was to have brain tumor surgery. During the operation, the reservoir was implanted; however, the ventricular tube broke and was immediately replaced with another device. The patient's status at the time of the report was alive-no injury.
Patient Sequence No: 1, Text Type: D, B5
[119657398]
The returned port met the requirements for leak testing. There was proteinaceous debris noted within the interior and exterior of the valve. Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve. The instructions for use (ifu) that accompany the device caution that? Shunt obstruction may occur in any of the components of the shunt system. The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.? The catheter was returned in two pieces of lengths 13 cm and 10 cm respectively. The tear site appeared to be jagged. It is unknown how or when the damage occurred. The returned segments were patent and passed leak testing when tested individually. The instructions for use (ifu) that accompany the device caution that? Low tear strength is a characteristic of most unreinforced silicone elastomer materials. Care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks or tears.? All ports and catheters are 100% inspected at the time of manufacture. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[126649976]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2018-00361 |
| MDR Report Key | 7704612 |
| Date Received | 2018-07-19 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-07-17 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2017-07-25 |
| Date Added to Maude | 2018-07-19 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| 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 | 0 |
| Brand Name | CSF VENTRICULAR PORT, 16 MM, SIDE INLET |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
| Product Code | LKG |
| Date Received | 2018-07-19 |
| Returned To Mfg | 2018-08-27 |
| Model Number | 44010 |
| Catalog Number | 44010 |
| Lot Number | E34897 |
| 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 | 2018-07-19 |