MAUDE Adverse Event Report: COVIDIEN DIALYSIS UNKNOWN; PALINDROME DIALYSIS CATHETER

Model Number UNK DIALYSIS

Device Problem Difficult to Remove (1528)

Patient Problems Adhesion(s) (1695); Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

Submit date: (b)(4) 2014.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter.The customer states the catheter was placed on (b)(6) 2013 and was in place for approx 6 weeks when it was removed on (b)(6) 2014.The pt is male, (b)(6) with renal insufficiency and awaiting a kidney transplant.During the mrt, it was found that the catheter was lying absolute correctly, but a thrombus was built at the wall of the atrium of heart and adhered with the catheter, dialysis could not be performed.There was no perforation of the wall of the atrium of heart.Due to the adhesion, the catheter could not be removed; the catheter had to be retrieved by surgery.The pt is urgently awaiting a kidney transplant; he is currently recovering from this surgery w/o any further complications.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: PALINDROME DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; 5439 state route 40; argyle NY 12809
• Manufacturer (Section G): COVIDIEN; 5439 state route 40; argyle NY 12809
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 3672161
• MDR Text Key: 15883259
• Report Number: 1317749-2014-00123
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK DIALYSIS
• Device Catalogue Number: UNK DIALYSIS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2014
• Initial Date FDA Received: 02/24/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR