MAUDE Adverse Event Report: COVIDIEN CURL CATH 62CM; CATHETER, HEMODIALYSIS, IMPLANTED

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Kinked (1339); Defective Component (2292); Malposition of Device (2616); Device Contamination with Chemical or Other Material (2944)

Patient Problem Tissue Damage (2104)

Event Date 05/11/2015

Event Type  malfunction  

Event Description

Chief complaint: a nonfunctioning peritoneal dialysis catheter for female presenting with history of renal failure.Peritoneal dialysis catheter was placed laparoscopically.This catheter became kinked, and was repositioned laparoscopically about a month later.At the time of the catheter repositioning, some debris was found within the catheter.This debris was removed and cultured.The cultures were negative.After having the revision, the catheter was used once or twice, but has mostly been nonfunctional.The fluid is able to be instilled, but it does not drain.A kidneys, uterus, bladder and contrast study were done, and i reviewed those images.These demonstrate that the catheter is in appropriate position, with no kinking of the catheter, and the contrast flows into the pelvis through the catheter.Patient had a procedure about a month after the repositioning.There was no fatty tissue adherent to the catheter.The omentum was not stuck to the catheter.There was no fibrinous material within the catheter.The catheter was flushed with normal saline and flushed easily.While flushing the catheter, i noticed a defect in the catheter, perhaps 5 cm inside the peritoneal cavity.This hole in the catheter was allowing fluid to leak out into the peritoneal cavity through this hole.I presumed that this was the cause of the inability of the catheter to function correctly.I made an incision in the skin over the insertion site of the catheter and removed the tissue ingrowth cuff from the rectus muscle with blunt dissection and electrocautery.Catheter was replaced with a new one and the patient was taken to recovery in stable condition postoperatively.

• Brand Name: CURL CATH 62CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 4790388
• MDR Text Key: 5878092
• Report Number: 4790388
• Device Sequence Number: 1
• Product Code: MSD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2015
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 76