MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NT821707, DRAINAGE KIT, LUMBAR

Model Number NT821707

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

Initial report ref to natus complaint (b)(4).Serial number of the device not confirmed.May 24, 2023: per information from the customer, the affected product will not be returned.Acceptable risk associated with the complaint as per hazard id 1.5 in doc-049039 natus external drainage lumbar catheters risk analysis spreadsheet.Risk is moderate.A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed.There are no capa's related to this issue and this complaint does not identify a deficiency in the product design and therefore a capa is not required.Further investigation to be carried out.

Event Description

Nt821707, drainage kit, lumbar - the lumbar drain was inserted by the anesthesiologist, no documented difficulty during insertion.On may 10th the lumbar drain was removed by a different anesthesiologist, documented the tip was intact.On may 13th the patient had a ct for chest, abdomen and pelvis.Observation was "epidural catheter within the spinal canal.On may 17th the patient underwent unilateral left-sided lumbar laminectomy and removal of the retained foreign body, followed by repair of the csf leak.

Event Description

Nt821707, drainage kit, lumbar - may 08, 2023 lumbar drain placed by anesthesiologist in the cardiovascular operating room, no immediate complications.May 10, 2023 lumbar drain discontinued by anesthesiologist, per documentation "lumbar drain site undressed and cleaned, catheter removed".Post removal, patient complained of ongoing headache and neck pain which was thought to be related to a cerebrospinal fluid (csf) leak.May 12, 2023 received blood patch for possible csf leak.May13, 2023 had follow up with a ct angiography on chest, abdomen, pelvis for post thoracic endovascular aortic repair follow up.Results: "there is an epidural catheter within the spinal canal.Catheter is at the level of the l2 vertebra and the spinal canal.It is noted posterior to the l2 vertebral body at the level of the l2-3 disc.The neurosurgeon is aware of the position of the catheter".Neurosurgery was consulted.On (b)(6) 2023, patient underwent unilateral left-sided lumbar laminectomy and removal of the retained foreign body, followed by repair of the cerebrospinal fluid leak.Microdissection.

Manufacturer Narrative

Follow up report 002 ref to natus complaint #(b)(4).(ref medsun mandatory and voluntary report form - uf /importer report# 0(b)(4).Dhr review: the device history record for the device was reviewed, the raw materials used in the manufacturing met specifications and there were no anomalies observed during the manufacturing, packaging or inspection of the device or accessories while in process.A review was also performed on the 80cm catheter lumbar assembly (b)(6), of which there were five different lots.All five lots met specifications during incoming inspection and in-process.Reference: capa005401 complaint history review/trend analysis: (24 months review and percent of sales) 4 previously confirmed "lnteg-broke in use" complaints within the past two years.(b)(4) nt821707 units sold within past two years.Failure rate = 0.09% root cause/failure investigation: the complaint could not be confirmed as the customer did not return the device for evaluation.A review of the device history record and the records of the lumbar catheter's material were reviewed.Product and catheter met specifications.Based on the- complaint reason of "catheter tip was sheared off and retained within the patient" a review of the capas opened within the last 12 months capa005401 was generated to investigate the root cause of the catheter shearing.Evaluation of the complaint descriptions and product tested performed (refer to capa005401) found the most likely cause of the lumbar catheter failure is due to its retraction during initial placement in the patient (either with or without the guidewire still populated in the catheter) while the tuohy needle remained in position.This resulted in the sharp heel edge of the touhy needle cutting through the lumbar catheter.The instructions for use (sd205456001 rev.Ab) contains several warnings to help prevent this from occurring in the field: page (5) five warning states 'to avoid damage to the catheter, care must be taken not to withdraw the catheter from the needle in order to reposition it in the subarachnoid space.If the catheter must be removed, withdraw the needle and catheter simultaneously".Page (5) five under precautions states: "silicone rubber tears and cuts easily.Use rubber shod forceps when handling the catheter".Page seven (7) warns: "warning: to minimize the risk of damage to the catheter, take care not to pull back on or withdraw the catheter after insertion into the needle.If the catheter must be removed, withdraw the needle and catheter simultaneously".Also, page seven (7) below step 7 list three caution statements: "caution: silicone tears and cuts easily.Use rubber shod forceps when handling silicone catheters"."caution: hold the catheter securely at the exit site during needle and guide wire removal to prevent catheter dislodgement"."caution: follow these points to aid needle and guide wire removal and to prevent damaging the catheter".Based on the investigation findings it appears that the user failed to comply with the precautions, warnings and multiple cautionary statements outline throughout the instructions for use.Unable to confirm if device failed to meet specifications as the, device was not returned for evaluation.Complaint will be included in trending data for further review.

Manufacturer Narrative

Follow up report 001 ref to natus complaint #(b)(4) (ref medsun mandatory and voluntary report form - uf /importer report# (b)(4) ).Further investigation to be carried out.

Event Description

(b)(6) , drainage kit, lumbar - (b)(6) 2023 lumbar drain placed by anesthesiologist in the cardiovascular operating room, no immediate complications.(b)(6) 2023 lumbar drain discontinued by anesthesiologist, per documentation "lumbar drain site undressed and cleaned, catheter removed".Post removal, patient complained of ongoing headache and neck pain which was thought to be related to a cerebrospinal fluid (csf) leak.(b)(6) 2023 received blood patch for possible csf leak.(b)(6) 2023 had follow up with a ct angiography on chest, abdomen, pelvis for post thoracic endovascular aortic repair follow up.Results: "there is an epidural catheter within the spinal canal.Catheter is at the level of the l2 vertebra and the spinal canal.It is noted posterior to the l2 vertebral body at the level of the l2-3 disc.The neurosurgeon is aware of the position of the catheter".Neurosurgery was consulted.(b)(6) 2023 patient underwent unilateral left-sided lumbar laminectomy and removal of the retained foreign body, followed by repair of the cerebrospinal fluid leak.Microdissection.

• Brand Name: NT821707, DRAINAGE KIT, LUMBAR
• Type of Device: NT821707, DRAINAGE KIT, LUMBAR
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): NATUS MANUFACURING LIMITED; ida business park; gort; galway, H91PD 92; EI H91PD92
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 17008872
• MDR Text Key: 316505931
• Report Number: 2023988-2023-00016
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT821707
• Device Catalogue Number: NT821707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Male