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

Model Number	8888123404P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/03/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during hd (hemodialysis) treatment, the catheter cracked.A crack of less than 2mm was noted in the lumen between the hub and the ports (clear part under the clamps) and caused leaks of blood during flushing.In order to resolve the issue, a new catheter was used.The customer stated that the patient was initially fine post dialysis; however, weeks after, the patient died due to myocardial infarction (mi).
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during hd (hemodialysis) treatment, the catheter cracked.A crack of less than 2mm was noted in the lumen between the hub and the ports (clear part under the clamps) and caused leaking of blood during flushing, there was blood loss of 1ml, no intervention was done and no transfusions required.In order to resolve the issue, a new catheter was used.There catheter was in place for 2 years.The patient's status was initially fine post dialysis, however weeks after the patient died due to myocardial infarction (mi) and the event was confirmed to be not related to the device issue.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8311545
• Report Number: 3009211636-2019-00024
• Device Sequence Number: 16675789
• Product Code: MSD
• UDI-Device Identifier: 10884521157774
• UDI-Public: 10884521157774
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2021
• Device Model Number: 8888123404P
• Device Catalogue Number: 8888123404P
• Device Lot Number: 1616800146
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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