MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LUMBAR CATHETER, CLOSED TIP; N/A

Model Number INS5010

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2022

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the hermetic lumbar catheter, closed tip (ins5010) guidewire was difficult to remove and that some of it may have been left in the patient.The surgeon stated that he was able to get the catheter in correct position but felt there may have been some stylet left in.However, he had good flow of csf and left the catheter in place for the duration of the case.The catheter was removed at the end of the case, and there was no apparent injuries to the patient.Surgeon estimated there was less than 15 minutes surgical delay.

Manufacturer Narrative

Hermetic lumbar catheter (ins5010) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Since the complaint is related to the health care professional (hcp) experience with the use of the device and not to a specific manufacturing defect, clinical affairs was consulted for additional support.The following information was provided: ¿the hcps should be experienced to perform this activity.Removal of the catheter should be performed with minimal force, and when resistance is encountered the patient should be placed in a flexed position to facilitate its removal.When hcps have difficulty with insertion there is a tendency to partially withdraw and then re-advance the catheter; the guidewire should never be withdrawn or turned through the tuohy needle after it has been inserted into the subarachnoid space.Once the weld on the guidewire breaks, the inner wire is separated from the outer wire and the outer wire will then be able to unwind whenever it encounters resistance upon removal.¿ as per ifu warning: ¿to avoid possible transection of the lumbar catheter, the catheter should never be withdrawn thorough the tuohy needle.If the catheter needs to be withdrawn, the tuohy needle and catheter (with guide wire if used) must be removed simultaneously¿.Therefore, based on clinical affairs evaluation and ifu warning, manipulation of catheter through the tuohy needle should be kept at minimum to avoid damaging the device; thus, guidewire removal should occur after tuohy needle has been removed.Therefore, the most probable root cause for the reported resistance is user technique related.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: HERMETIC LUMBAR CATHETER, CLOSED TIP
• 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
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15564416
• MDR Text Key: 306350572
• Report Number: 2648988-2022-00020
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780071082
• UDI-Public: 10381780071082
• Combination Product (y/n): N
• PMA/PMN Number: K972994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS5010
• Device Catalogue Number: INS5010
• Device Lot Number: 6454666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2022
• Date Device Manufactured: 07/18/2022
• 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