MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN LLC. MEDTRONIC PALINDROME PRECISION CHRONIC HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Lot Number	8888145048P
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/01/2022
Type of Reportable Event	Death
Event or Problem Description
Patient admitted (b)(6) 2022.Perm hd catheter inserted (b)(6) 2022.Seal alert regarding recall of affected catheters from medtronic received 7/8/2022.Alert states that medtronic has identified potential leaking at the hub and recalls the affected devices.Patient identified to have a central line associated blood stream infection (clabsi) with date of event (b)(6) 2022.Patient then expired (b)(6) 2022 with affected line in place and in use.Positive 2/4 bottles enterococcus faecalis.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC PALINDROME PRECISION CHRONIC HEMODIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MEDTRONIC / COVIDIEN LLC.
• MDR Report Key: 15192147
• Report Number: MW5111337
• Device Sequence Number: 2162239
• Product Code: MSD
• UDI-Device Identifier: 20884521158150
• UDI-Public: 20884521158150
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/05/2022

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 Lot Number: 8888145048P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2022
• 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: Death; Life Threatening
• Patient Sex: Unknown
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic