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

Model Number 8888145049

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 9763729
• MDR Text Key: 194338864
• Report Number: 3009211636-2020-00058
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521017818
• UDI-Public: 10884521017818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 02/27/2020
• Date Device Manufactured: 07/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1