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

Catalog Number 910121

Device Problem Material Fragmentation (1261)

Patient Problems Pain (1994); Needle Stick/Puncture (2462)

Event Type  Injury  

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 during use on a patient, the wire of the lumbar cath.Access.Kit (910121) dissolved into its component parts when pulled out (approx.In the middle), and it literally splintered.No residue of the product remained in the patient.Another device was used to complete the procedure which resulted in ten minutes extension of surgery time.Additionally, a new puncture of the patient's spinal canal was necessary, thus there was increased risk of spinal epidural hematoma and pain during the procedure due to necessary reattachment.

Manufacturer Narrative

The lumbar catheter (910121)was returned for evaluation: device history record (dhr) - the dhr was reviewed and did not reveal any anomaly that could explain the reported event.No similar complaint was received for a product from this batch.Failure analysis - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.The lumbar catheter was received cut in 3 pieces, guidewire was inserted in a part of catheter.Inspection of catheter showed breakage: the edges are not straight, indicating breakage was not related to a scalpel cut but likely to excessive traction.Dimensional verifications showed length/diameter to be within specifications.Guidewire was removed from catheter and inspected: it was broken at around 4cm of the tip at the level of a kink.Guidewire was sent to the supplier for further analysis: ¿the returned distal section was stretched and unraveled.Closer examination revealed that the fracture occurred on core tapper approximately 3.7 cm from the distal tip.The microscopic examination of the fracture point showed evidence of a ductile fracture.Root cause -complaint is verified but its exact root cause could not be determined by the investigation.Dimensional inspections show all released products were within specifications.Design and manufacturing changes were reviewed for the guidewire and lumbar catheter and none could explain the reported event.As integra received a higher number of similar complaints in q3 2021 compared to previous years, a specific complaint trend analysis has been triggered and a corrective action has been initiated to extend investigation.No additional action is deemed required pending results of the corrective action investigations.At present, we consider this complaint to be closed.

• 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: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12377247
• MDR Text Key: 268460395
• Report Number: 9612007-2021-00031
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K862513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 910121
• Device Lot Number: 0221854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• 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