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

Lot Number	8888145057P
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Date of Event	07/10/2022
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.Perm hd catheter removed (b)(6) 2022 and tip sent for culture.Patient then expired (b)(6) 2022.Fda safety report id# (b)(4).
Event or Problem Description
Additional information received on 08/12/2022 for report mw511139 for procode.

• Brand Name: MEDTRONIC PALINDROME PRECISION CHRONIC HEMODIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MEDTRONIC / COVIDIEN LLC.
• MDR Report Key: 15192168
• Report Number: MW5111339
• Device Sequence Number: 2162240
• Product Code: MSD
• UDI-Device Identifier: 20884521158273
• UDI-Public: 20884521158273
• 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
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 8888145057P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 08/12/2022
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Hispanic