MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LUMBAR CATHETER; N/A

Catalog Number XXX-HERMETIC LUMBAR CATHETER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

Additional information was received on 26jul2018 indicating that a (b)(6) male patient had the drain inserted a day before the surgery.The cerebrospinal fluid (csf) was drained for 3 days and the drain was removed on "pod 4".

Event Description

N/a.

• Brand Name: LUMBAR CATHETER
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7154925
• MDR Text Key: 96072272
• Report Number: 2648988-2017-00075
• Device Sequence Number: 1
• Product Code: HBG
• Combination Product (y/n): N
• PMA/PMN Number: K961113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-HERMETIC LUMBAR CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 01/17/2018; 07/26/2018
• Supplement Dates FDA Received: 01/26/2018; 08/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR