MAUDE Adverse Event Report: COVIDIEN LP MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	8888221316
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The event involved an elderly female with a past medical history of thrombocytopenia, hypertension, and hyperlipidemia.The patient was admitted with altered mental status and acute kidney injury, later diagnosed with microangiopathic hemolytic anemia.On [redacted date], an experienced intensive care unit (icu) provider inserted a left internal jugular double lumen central line catheter for plasmapheresis treatment.The provider followed the standard icu practice without complications.That night, despite the lines flushing well, there was poor blood return and sluggish flow noted during plasmapheresis treatment.Consequently, the icu team decided to insert a second double lumen central line catheter and remove the first central line catheter.The removal of the left internal jugular catheter was performed at the icu bedside per the standard of practice.The icu provider that removed the catheter inspected and noted that the catheter tip was intact.A chest computerized tomography (ct) on [redacted date] revealed a foreign body in the right lower pulmonary artery.On [redacted date] had the foreign body removed without complications.The foreign body was determined to be a retained catheter tip.Manufacturer response for catheter, hemodialysis, non-implanted, mahurkar elite (per site reporter).Covidien rep notified by our materials management team.

• Brand Name: MAHURKAR ELITE
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 20047742
• Report Number: 20047742
• Device Sequence Number: 12746009
• Product Code: MPB
• UDI-Device Identifier: 10884521126374
• UDI-Public: 10884521126374
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2024
• Report Date (Section F): 08/22/2024

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
• Device Model Number: 8888221316
• Device Catalogue Number: 8888221316
• Device Lot Number: 240300011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2024
• 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: Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/22/2024