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

Model Number 8888145041P

Device Problems Product Quality Problem (1506); Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, 30 minutes into catheter insertion, it was stated that there was difficulty inserting the stylet into the catheter.It was difficult to advance the product (stylet) and it was said that it had kinked at multiple places during introduction.The inside of the catheter was flushed with physiological saline prior to the insertion of the device (stylet) and the stylet was introduced with the white surface facing the center of the catheter.The product (stylet) was inserted while being held between 2 to 3 cm from the hub and the branch part was not clamped during the process.It was also reported that during the insertion of the guidewire, issues such as difficult to be inserted into the stylet and the feeling of being stuck when being inserted were observed.It was told that the catheter had kinked as well near the insertion site and blood did not flow initially.The device (catheter) was moved near the exit site to resolve the issue.It was later said that although poor blood removal had occured sporadically, blood removal and blood return were able to be performed by changing the patient's body position to correct the issue thus the placement was continued.Seldinger method was the procedure method used (sheath introducer method was not used) and the patient was said to be under local anesthesia.The placement site was reportedly done in the right jugular vein of the patient.For the subcutaneous tunnel, the caudal exit was located between 2 to 3 cm inside the nipple and between 3 to 4 cm at cranial site.The cranial exit was located at 1 cm outside of the guidewire insertion part.There was no package damage noted and nothing unusual was observed on all the reported components (stylet, guidewire and catheter shaft).There was no reported patient injury.

• 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: 9681383
• MDR Text Key: 194338121
• Report Number: 3009211636-2020-00036
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521158047
• UDI-Public: 10884521158047
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145041P
• Device Catalogue Number: 8888145041P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2020
• 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
• Patient Weight: 52