MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for ALGOLINE CATHETER KIT 81102 manufactured by Medtronic Neurosurgery.
[112301664]
Patient scheduled for placement of trial intrathecal catheter at cervical one. When procedure was aborted due to difficulty encountered while attempting to pass the catheter through an arachnoid web, the catheter was withdrawn from the tuohy needle, and approximately five centimeters of the catheter was retained in the intrathecal space. The patient will be offered other treatment options.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7637232 |
| MDR Report Key | 7637232 |
| Date Received | 2018-06-26 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-04-13 |
| Report Date | 2018-06-19 |
| Date Reported to FDA | 2018-06-19 |
| Date Reported to Mfgr | 2018-06-26 |
| Date Added to Maude | 2018-06-26 |
| 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 | ALGOLINE CATHETER KIT |
| Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL |
| Product Code | MAJ |
| Date Received | 2018-06-26 |
| Model Number | 81102 |
| Lot Number | D070952 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-06-26 |