MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN LUMBAR CATHETER KIT II; CENTRAL NERVOUS SYSTEM FLUID SHUNT

Model Number 82-1707

Device Problems Break (1069); Failure to Advance (2524); Physical Resistance (2578); Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2017

Event Type  Injury  

Event Description

As reported (b)(6) 2017 by codman to natus: "as reported by the ous affiliate, a lumbar catheter could not be inserted into the spine canal because of resistance with another device.The physician attempted to withdraw the device; however, the catheter broke/separated and the separated portion was retained in the patient.There is no report of attempt to remove the retained portion." as no further information was provided related to the patient, the extent of the possible delay in surgery, and whether or not remedial procedure was required, additional information will be requested.

Manufacturer Narrative

Added 26 jan 2018: information received 15 jan 2018 from codman in provided complaint report "complaints (b)(4)" (last updated on jan 15, 2018): "the part of broken piece was retained in the patient and not retrieved.However the size is unknown.And there is resistance between the device and some other device".Based on the information provided in the above mentioned report, natus had completed its investigation.The investigation included: methods: review of device history records evaluation of the actual device review of complaints history/trends analysis review of past capas/capa determination.Results: the catheter was returned for evaluation.A review of manufacturing records found no discrepancies when the device was released to stock.Evaluation of the returned device found the root cause of the lumbar catheter failure was due to its retraction during initial placement in the patient (either with or without the guidewire still populated in the catheter) while the tuohy needle remained in position.This resulted in the sharp heel edge of the needle cutting through the lumbar catheter.The lumbar catheter kit ifu (ifu-lcn-205456001) has the following 2 warnings to help prevent this from occurring in the field."to avoid damage to the catheter, care must be taken not to withdraw the catheter from the needle in order to reposition it in the subarachnoid space.If the catheter must be removed, withdraw the needle and catheter simultaneously." "warning: to minimize the risk of damage tot he catheter, take care not to pull back on or withdraw the catheter after insertion into the needle.If the catheter must be removed, withdraw the needle and catheter simultaneously." a review of complaint records for the previous 12 months found no similar complaints against this lot and product code combination.Trends will be monitored for this or similar complaints.Prior action taken: c/a not taken.Is further corrective & preventative actions proposed? no.The complaint has been confirmed and is not deemed closed.

Manufacturer Narrative

Added 29 jan 2018: erroneously reported in follow-up 1, the complaint is not deemed still open, but in-fact, is now deemed closed.

• Brand Name: CODMAN LUMBAR CATHETER KIT II
• Type of Device: CENTRAL NERVOUS SYSTEM FLUID SHUNT
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7189971
• MDR Text Key: 97336799
• Report Number: 2023988-2018-00002
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704040811
• UDI-Public: 10886704040811
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: 82-1707
• Device Catalogue Number: 821707
• Device Lot Number: 570646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• Patient Sequence Number: 1
• Patient Outcome(s): Other