MAUDE Adverse Event Report: MEDCOMP 14F X 28CM SPLIT STREAM; HEMODIALYSIS CATHETER

Model Number SST28SE.

Device Problems Fluid/Blood Leak (1250); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

Received one 14f x 28cm split stream catheter for evaluation.A visual inspection reveals the catheter to be in 3 pieces.A small hole in the arterial lumen at the point where the lumens are bonded together was noted.A review of the manufacturing records was not possible as the lot number was not provided.The split stream catheter is manufactured by bonding two lumens together allowing the distal portion of the lumens to be separated by the physician as deemed appropriate.The proximal portion of the lumen is permanently bonded.Based on the sample review, the hole appears to be caused by stress in the transition area from "d" to "o".(this is the area where the shape of the lumens changes to create a flat surface that can be bonded together).Stress at this area can be caused by the operator manipulating the device during site care and during the dialysis treatment.The report indicated the catheter was implanted for 1.5 years with no reported problems.There is no evidence of swelling, crumbling, discoloration, degradation or polymer variation of the lumen and extension material.We are unable to determine the cause or factors that may have contributed to this event.There is no evidence of a manufacturing problem.

Event Description

After 1.5 years in situ the nurse noticed leakage from rip/tear in the catheter at the y- junction.

• Brand Name: 14F X 28CM SPLIT STREAM
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: susan smith ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 5871300
• MDR Text Key: 53037946
• Report Number: 2518902-2016-00023
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SST28SE.
• Device Catalogue Number: SST28SE.
• Other Device ID Number: 884908050073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention