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

Model Number	82-1707
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Natus completed their investigation.Investigation results received on 16july2018 as follows: investigation summary: as reported by the ous affiliate, a lumbar catheter broke off in the patient while being implanted.It is suspected that the device was not irrigated adequately an rx exam was performed to detect the fragment in the patient and it was decided by the neurosurgeon not to perform a revision surgery.There were no reports of delay or patient harm.Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.A review of complaint records for the previous 12 months could not be performed as no lot number information was provided.The most recent complaint and smt presentation was reviewed and did not show that this product family exceeded its upper control limit for complaints.Investigation methods/evaluation results: complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.Root cause category: undetermined : insufficient information.Failure code: codman : product analysis : device not returned (device was discarded).Root cause description: complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.No further corrective & preventative actions proposed.Document rationale for no corrective action: no corrective action required based on the above evaluation.Trends will be monitored for this or similar complaints.This complaint is now deemed closed.
Event or Problem Description
As reported by the ous affiliate, a lumbar catheter broke off in the patient while being implanted.It is suspected that the device was not irrigated adequately an rx exam was performed to detect the fragment in the patient and it was decided by the neurosurgeon not to perform a revision surgery.There were no reports of delay or patient harm.Patient information: no information.Patient is not part of a clinical study.This is not a revision of one or more implants.

• Brand Name: CODMAN LUMBAR DRAINAGE CATHETER KIT II
• Common Device Name: CENTRAL NERVOUS SYSTEM FLUID SHUNT AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7696048
• Report Number: 2023988-2018-00041
• Device Sequence Number: 19195633
• Product Code: JXG
• UDI-Device Identifier: 10886704040811
• UDI-Public: 10886704040811
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K964923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 82-1707
• Device Catalogue Number: 821707
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention