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

Catalog Number NL8508330

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

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 line of the hermetic lumbar catheter (b)(4) broke without any unnecessary force applied to it during insertion of the accessory kit to drain cerebrospinal fluid from lumbar area.The broken catheter was removed from the patient without any adverse outcome.There was a 5 minute delay in surgery and postoperatively, the patient's condition was good.

Manufacturer Narrative

Unique device identifier: (b)(4).Hermetic lumbar catheter (nl8508330) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.A possible root cause may be related to the insertion process.If catheter is being repositioned and moved backwards through the tuohy needle, the catheter may be cut or transected without applying excessive force or ¿unnecessary force¿ - as stated in the complaint.The cause(s) of the difficulty reported by the customer could not be determined.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.

Manufacturer Narrative

The lumbar catheter was returned for evaluation: dhr - no anomaly was noticed during the process of this lot that could be related to the reported condition.Failure analysis - one (1) catheter was received.The package contained a catheter broken in two (2) parts, a touhy needle, a connector, and a stopcock.The product lot number could not be confirmed since the product was used and the original package was not included.The cut area was magnified and straight edges were observed in areas of the broken section as if cut (or partially cut) with a sharp instrument.This is consistent with what happens when repositioning the catheter through the touhy needle during insertion.This is also consistent with the report that it did not require ¿unnecessary force¿ for the breakage to occur.The reported condition ¿catheter line broke during insertion¿ is considered confirmed.Root cause - straight edges were observed in the broken area that appear to be consistent with ¿cutting¿ the silicone tube with a sharp object.Therefore, the most probable cause for the breakage is related to the catheter insertion process.If catheter is being repositioned and moved backwards through the tuohy needle, the catheter may be cut or transected without applying excessive force or ¿unnecessary force¿ - as stated in the complaint.An excerpt from ifu¿s precautions section states as follows: ¿to avoid possible transection of the lumbar catheter, the catheter should never be withdrawn through the touhy needle.If the catheter needs to be withdrawn, the touhy needle and catheter (with guide wire if used) must be removed simultaneously.¿ the ifu also states the following: ¿the silicone elastomer tubing should be carefully secured to the connector with ligatures in such a manner as to avoid cutting of the tubing.¿.

• Brand Name: HERMETIC LUMBAR CATHETER, OPEN 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 00610
• MDR Report Key: 11242495
• MDR Text Key: 252210403
• Report Number: 2648988-2021-00001
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL8508330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1