MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2017-12-29 for LUMBAR CATHETER XXX-HERMETIC LUMBAR CATHETER manufactured by Integra Neurosciences Pr.
[96072272]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[96072273]
This report is for the second patient who had blood-tinged pink csf observed in immediate postoperative period. Anesthesia analgesia (2017) published fluoroscopic-guided lumbar spinal drain insertion for thoracic aortic aneurysm surgery which studies csf drainage in taaa open and endovascular repair to aid in the prevention and management of sci. This report discussed 3 patients sample who developed mild postoperative complications related to spinal drain management of sci. First, patient suffered from csf leak after drain removal that resolved spontaneously after 4 hours of keeping flat and avoiding head elevation greater than 30 degree. Second, blood-tinged pink csf was observed in another patient in the immediate postoperative period. The last patient developed a postoperative dural puncture headache on the postoperative day. The study concluded that fluoroscopic-guided spinal drain insertion by interventional neuroradiologists using fluoroscopy can be a backup for anesthesiologists when they face difficult or failed drain insertions, and they can also be used in patients with known coagulopathy. Two patients within this case series had their drains inserted on the first postoperative day, as opposed to the pre-operative period, for management of postoperative paralysis. One patient presented for an emergency thoracic endovascular aortic aneurysm repair (tevar) for ruptured taaa, and we were not able to insert a drain preoperatively. The second patient underwent fenestrated endovascular aortic repair (fevar) for treatment of abdominal aortic aneurysm. Because he was considered low risk for the development of sci, the drain was not inserted preoperatively. Both patients were referred to the intervention neuroradiologist for lumbar spinal drain insertion because of coagulopathy (platelet count: 97,000 cell/ ul; international normalized ratio: 1. 4 and 1. 5 for patients 1 and 2, respectively. Linked to mfg report numbers: 2648988-2017-00074 and 2648988-2017-00076.
Patient Sequence No: 1, Text Type: D, B5
[110915656]
Investigation completed on (b)(6) 2018. The events were not attributed to the use of the device in the evaluated report (no product failure was reported); no lot number was reported for documentation review; and no units were returned to confirm the complaint. No further investigation is possible; the root cause for these events is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648988-2017-00075 |
| MDR Report Key | 7154925 |
| Report Source | LITERATURE |
| Date Received | 2017-12-29 |
| Date of Report | 2017-12-06 |
| Date Mfgr Received | 2018-07-26 |
| Date Added to Maude | 2017-12-29 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES PR |
| Manufacturer Street | ROAD 402 NORTH, KM 1.2 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMBAR CATHETER |
| Generic Name | N/A |
| Product Code | HBG |
| Date Received | 2017-12-29 |
| Catalog Number | XXX-HERMETIC LUMBAR CATHETER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES PR |
| Manufacturer Address | ROAD 402 NORTH, KM 1.2 ROAD 402 NORTH, KM 1.2 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-29 |