MAUDE Adverse Event Report: MEDCOMP 10FX18CM HEMO-CATH; HEMODIALYSIS CATHETER

Model Number MC101042P

Device Problem Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 05/05/2015

Event Type  Injury  

Event Description

Accidental finding on chest x-ray done (b)(6) 2015.Catheter piece sitting on left pulmonary artery.Dialysis service questioned if they had noticed any issues when dialyzing patient.They had not, patient had not experienced any issues.Chest x-ray was being done pre surgery for renal.Had to snare catheter piece and exchange cvl.Patient required extra procedure under anesthesia.

Manufacturer Narrative

A visual inspection of the catheter sample revealed both extensions were cut 1.5cm from the hub.The venous lumen tip is missing and was not returned.A review of the manufacturing records indicated that all device specifications and quality requirements were satisfied.The venous lumen tip was measured.All measurements were within the design specifications.There is no evidence of swelling, crumbling, discoloration, degradation or polymer variation of the lumen material.There is no evidence of a manufacturing problem.The device was implanted in (b)(6) 2015 and the missing tip was an "accidental finding on chest x-ray done (b)(6) 2015".There is no way to determine when the tip of the catheter broke off.It is unlikely that the tip spontaneously broke off unless it was damaged during the insertion procedure.We are unable to determine the root cause of this event.

• Brand Name: 10FX18CM HEMO-CATH
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; harleysville PA
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: susan smith, rn ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 4810597
• MDR Text Key: 5916144
• Report Number: 2518902-2015-00055
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2015

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 Expiration Date: 02/28/2016
• Device Model Number: MC101042P
• Device Catalogue Number: MC101042P
• Device Lot Number: MBKK030
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2012
• 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
• Patient Age: 2 YR