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

Catalog Number INS5010

Device Problem Difficult to Remove (1528)

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

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 it appeared that the tip broke off.The surgeon was not sure if any of the wire was left in the patient.No injuries to the patient was reported and delay in surgery is unknown.

Manufacturer Narrative

Hermetic lumbar catheter (ins5010) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.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insertion there is a tendency to partially withdraw and then re-advance the catheter; the guidewire should never be withdrawn or turned through the tuohy needle after it has been inserted into the subarachnoid space.Once the weld on the guidewire breaks, the inner wire is separated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.¿ 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: 15827033
• MDR Text Key: 307989400
• Report Number: 2648988-2022-00022
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K972994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS5010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• 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