MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA LUMBAR CATH. ACCESS. KIT (LCAK); EXTERNAL DRAINAGE ACCESSORIES

Catalog Number 910121

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913); Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2016

Event Type  malfunction  

Event Description

This is the first of two reports (same facility, same product problem, different product id).Linked to mfg report: 2648988-2016-00025.Reports were received for the 910121 lumbar catheter and the ins5010 catheter having issues with the placement.On (b)(6) 2016, the physician could not withdraw the guide wire from the silicone catheter without it crimping.He confirmed that he had both irrigated the catheter and guide wire (in the case of the 910121) just prior to placement.He could not remove the silicone catheter from the tuohy needle, once it was inserted into the patient, without concern of the tip being sheered off and left lodged in the patient.The product problems led to a 15 minute increase in surgery time.The patient was not harmed or injured as a result of the incident.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 23 aug 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: the received lumbar catheter was damaged and the guide-wire featured many kinks.Dimensional inspections of the guide-wire did not reveal any anomaly.Visual inspection of the catheter tip suggests it was not torn by the tuohy needle, but possibly by the guide-wire.The complaint also stated the user ¿could not remove the silicone catheter from the tuohy needle once inserted in to the patient, without concern of the tip being sheared off and left lodged in the patient¿.The catheter is never supposed to be removed from tuohy needle.As stressed in the product ifu, if the catheter needs to be withdrawn, the tuohy needle and catheter (with guide-wire) must be removed simultaneously in order to prevent catheter damage.The device lot number could not be obtained, no device history records review could be performed.Upon review of integra¿s complaint system since january 2013, a total of (b)(4) complaints (including this one) for lumbar catheter accessory kit (catalogs: 910121, 910120a/n, 910420) have been reported for ¿difficulty of insertion/removal of the guide-wire¿.The distribution is as follows: (b)(4) in 2013, (b)(4) in 2014 , (b)(4) in 2015 and (b)(4) in 2016.Approximately (b)(4) units of lcak have been sold since 2013, resulting in a complaint occurrence rate of (b)(4)%.No trend is observed.Conclusion: the complaint is verified, the catheter/assembly presented kinks that may impair catheter removal.The most likely cause of the reported ¿crimp¿ is a kink of the device assembly during insertion: the guide-wire kink interferes with its removal.The device failure analysis and the manufacturing controls allow to consider a manufacturing defect as unlikely.A flush with bacitracin solution may also impair insertion/removal of the guide-wire as stated in the product instructions for use.

• Brand Name: LUMBAR CATH. ACCESS. KIT (LCAK)
• Type of Device: EXTERNAL DRAINAGE ACCESSORIES
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5701880
• MDR Text Key: 47903387
• Report Number: 9612007-2016-00011
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K032817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 910121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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