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

Model Number	8888145040
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190); No Code Available (3191)
Date of Event	01/26/2019
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, during treatment when the patient was connected to the machine, there was a leak and a hole was found in the venous lumen within the white clamp segment of the catheter.It was noted that the catheter was completely explanted.There was no reported patient outcome.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient's vital signs were stable within normal range and no abnormalities were noted, however, the staff could only achieve a blood flow rate of 250 ml/min instead of the desired 300 ml/min due to a high negative arterial pressure.During treatment when the patient was connected to the machine, there was a leak and a hole was found in the venous lumen within the white clamp segment of the catheter.It was noted that a tego was not utilized and the patient has a history of hypertension.The access was clamped off after the dialysis was abandoned.The exit site was left with the dressing intact and the catheter lumens were disinfected with 2% chlorhexidine in 70% alcohol per the hospital policy.The patient was readmitted in the hospital and the catheter was completely explanted.Peritoneal dialysis was the long term access for the patient's dialysis but an attempt was made to insert a new catheter via the left internal jugular.The attempt failed as they were unable to pass through the central veins and superior vena cava, hence, a new temporary access was inserted in the femoral vein.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 8457284
• Report Number: 3009211636-2019-00070
• Device Sequence Number: 2887986
• Product Code: MSD
• UDI-Device Identifier: 10884521056664
• UDI-Public: 10884521056664
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/16/2019

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: 03/20/2023
• Device Model Number: 8888145040
• Device Catalogue Number: 8888145040
• Device Lot Number: 1810400151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/17/2019; 04/04/2019; 06/28/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/04/2019; 04/23/2019; 07/16/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 27 YR