MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145049
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient was having a replacement of the left jugular tunneled catheter over a wire.Intra-operatively, the sheath broke when the surgeon was exchanging the blue sheath that goes into the center of the lumen in a patient with end-stage renal disease with dysfunctional left jugular tunneled catheter.When the surgeon attempted to remove the sheath, all pieces were removed and accounted for.After a third attempt, a new catheter was inserted without incident.Post-operative chest x-ray was done which showed dialysis catheter tip projects over the junction of superior vena cava and right atrium.There was no pneumothorax.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• MDR Report Key: 9763729
• Report Number: 3009211636-2020-00058
• Device Sequence Number: 10934762
• Product Code: MSD
• UDI-Device Identifier: 10884521017818
• UDI-Public: 10884521017818
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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 Expiration Date: 06/07/2021
• Device Model Number: 8888145049
• Device Catalogue Number: 8888145049
• Device Lot Number: 1818500187
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1