MAUDE Adverse Event Report: MOZARC MEDICAL US LLC PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145039P
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Obstruction/Occlusion (2422); Reduced Blood Flow (4598); Hemodynamic instability (4868)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Injury occurred, pulmonary air embolus.During placement of tunneled central venous catheter, the peel away sheath valve failed and a large bolus of air was sucked into the sheath and into the heart prompting immediate advanced airway procedures, patient repositioning, and emergent anesthesia response.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MOZARC MEDICAL US LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 25277324
• Report Number: 25277324
• Device Sequence Number: 13187515
• Product Code: MSD
• UDI-Device Identifier: 10884521158023
• UDI-Public: (01)10884521158023(17)300103(10)2430500182
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/29/2026
• Report Date (Section F): 04/29/2026

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: 8888145039P
• Device Lot Number: 2430500182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/29/2026