MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN LUMBER CATHETER KIT; SHUNT, NERVOUS SYSTEM & COMPS

Model Number	82-1707
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
1 of 2 reports.(same patient, same event, different products) other mfg report number: 2648988-2022-00017.A facility reported a lumbar catheter kit (id 821707) was used for lumbar drainage to evacuate excess csf on an adult patient.During external lumbar derivation, after use of trocar (included into the kit), and the introduction of derivation catheter with mandrel, it was impossible to remove the mandrel, which finally tore the catheter.The medical team is wondering if the entire catheter was completely removed (did not lose some parts).However, the patient was not injured, but the dysfunction led to increased surgery time (customer did not know for how long).The customer is unaware of how the patient is doing now.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The catheter was returned for evaluation: dhr - no anomalies occurred during the manufacturing process.Failure analysis - product was returned to the analysis site for failure analysis, and the following was performed on the returned unit: the analysis site provided photos of the returned unit, in which you can visualize that the catheter is torn with the stylet/guidewire still inserted.The complaint is confirmed.Root cause - per the complaint background, catheter was torn.The complaint was confirmed in the complaint investigation.The likely root cause includes stylet interference with catheter wall.
Event or Problem Description
N/a.

• Brand Name: CODMAN LUMBER CATHETER KIT
• Common Device Name: SHUNT, NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15319972
• Report Number: 3014334038-2022-00186
• Device Sequence Number: 5227186
• Product Code: JXG
• UDI-Device Identifier: 10886704040811
• UDI-Public: 10886704040811
• Combination Product (Y/N): N
• PMA/510(K) Number: K964923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 82-1707
• Device Catalogue Number: 821707
• Device Lot Number: J67H20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown