MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT

Description of Event or Problem

MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - DURING THE IMPLANTATION PROCESS, IT WAS FOUND THAT THE SILICONE TUBE OF THE VENTRICULAR CHANNEL WAS BROKEN.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT # (B)(4). STERILE DATE: (B)(6) 2023. DEVICE HISTORY REVIEW: UNIT HAS PASSED ALL THE REQUIRED TESTS. NO MANUFACTURING DEFECTS OR NON-CONFORMANCES OBSERVED. NO ASSOCIATED CAPAS. RISK MANAGEMENT REVIEW: A REVIEW OF (B)(4) MEDICAL DEVICE HAZARD ANALYSIS (REV 05), IDENTIFIES THE HAZARD SITUATION AS "6.4 SILICONE SHEARS OFF CATHETER TIP DURING INSERTION OR REMOVAL: A) SILICONE MATERIAL, TOLERANCING VS. STYLET, OR SILICONE ATTACHMENT INSUFFICIENT / NON-ROBUST FOR INTENDED USE B) PHYSICIAN INADVERTENTLY TEARS SILICON WITH STYLET OR CATHETER" BASED ON COMPLAINT OF "SILICONE TUBE RUPTURES." THE RISK LEVEL IS CONSIDERED LOW. THIS DETERMINATION IS BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER. ROOT CAUSE/FAILURE INVESTIGATION: THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION OR PROVIDE ADDITIONAL DETAILS REGARDING THE DEVICE. THE DEVICE HISTORY RECORDS SHOW SPECIFICATIONS WERE MET PRIOR TO RELEASE OF PRODUCT. COMPLAINT DATA WILL BE TRACKED AND TRENDED FOR RECURRENCE. NO FURTHER ACTION IS REQUIRED. FAILURE MODE: N/A - NOT RETURNED.

Description of Event or Problem

MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - DURING THE IMPLANTATION PROCESS, IT WAS FOUND THAT THE SILICONE TUBE OF THE VENTRICULAR CHANNEL WAS BROKEN.

Additional Manufacturer Narrative

INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). PER (B)(4) REV 05 CAMINO110-4 SERIES INTRACRANIAL PRESSURE/TEMPERATURE CATHETERS AND ACCESSORIES - RISK ANALYSIS SPREADSHEET, (RAS). HAZARD ID 6.4 SILICONE SHEARS OFF CATHETER TIP DURING INSERTION OR REMOVAL: A) SILICONE MATERIAL, TOLERANCING VS. STYLET, OR SILICONE ATTACHMENT INSUFFICIENT / NON-ROBUST FOR INTENDED USE B) PHYSICIAN INADVERTENTLY TEARS SILICON WITH STYLET OR CATHETER EFFECTS (HARM): INFLAMMATION; LOCAL TOXICITY; SYSTEMIC TOXICITY RESIDUAL RISK: MINOR. THE HAZARDS IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE BENEFIT OF USE OF THE ENTIRE PRODUCT OUTWEIGHS THE RISKS IDENTIFIED. REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER, AND AWAITING RESPONSE. FURTHER INVESTIGATION TO BE CARRIED OUT.