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

Model Number 8888145040P

Device Problems Material Frayed (1262); Product Quality Problem (1506); Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during catheter insertion in the right internal jugular vein using the seldinger method (sheath/introducer not used), there was difficulty noted while inserting the stylet as it was very difficulty to advance.Once the stylet got inserted, the stylet kinked at multiple places.The catheter was flushed with physiological saline prior to use with no issues noted.There was nothing unusual observed on the device prior to use.The dimensions of the catheter matched what was indicated in the label and the guide wire that was used was the guide wire provided in the kit.It was noted that the white surface of the stylet was inserted into the catheter (branch part was not clamped).The guide wire that was also mentioned to be difficult to insert (feeling of stuck) was advanced through the tip of the long stylet and short stylet and was then inserted into the stylet.The catheter got kinked near the insertion site and blood did not flow as the catheter was occluded.In the subcutaneous tunnel, the tail-side exit was located 2-3 cm inside and 3-4 cm head-side from the nipple, and the head-side exit was located 1 cm outside the guide wire insertion part.The guide wire was also kinked and could not be removed.It was noted that the guide wire got bent and was straying across the arterial and venous sides of the catheter.There was difficulty encountered while removing the guide wire and excessive force was used to remove the guide wire.The catheter was then removed in order to completely remove the guide wire and a new device was used in order to resolve the issue.It was confirmed that the catheter and the guide wire were removed simultaneously from the patient to prevent the risk of rupture of the guide wire.The guide wire was confirmed to be completely removed and intact.There was no blood loss and no need for blood transfusion.The procedure was completed after the device was replaced.There was no other intervention required as a result of the issue.There was no reported patient injury at the time of the event but an x-ray post procedure was done.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the device noted that only the guide wire was frayed , unraveled and stuck in the cannula.The guide wire could not be removed.Functional testing: functional testing would normally include leak testing however the guide wire could not be removed from the cannula precluding this type of testing.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the coiled and unraveled guide wire stuck in the cannula may occur when excessive force is applied during clinical application.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9681528
• MDR Text Key: 178155273
• Report Number: 3009211636-2020-00037
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521158030
• UDI-Public: 10884521158030
• Combination Product (y/n): N
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145040P
• Device Catalogue Number: 8888145040P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 52