MAUDE Adverse Event Report: MILLAR INC. MIKRO-CATH PRESSURE CATHETER

Model Number 825-0101

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

A follow-up call with the doctor was done.The doctor informed millar of the following.Dr.(b)(6) called to inform a chest x-ray was performed on the patient and 5mm of the remaining catheter was located by the patient's fascia near the lvad.The tip appears to be 4cm deep in the skin.The patient has requested not to intervene to remove the portion of remaining catheter.Millar is unable to perform an evaluation on the catheter because it will not be returned.The catheter was discarded after the procedure, according to the doctor.Millar did perform a review of the device history records, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with the mikro-cath specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.Device not returned.Device discarded.

Event Description

The mikro-cath was placed in the left atrium of the patient during o.R placement of a left ventricular assist device lvad.The mikro-cath was passed through the chest wall using a peel-away long needle catheter and placed in the left atrium via access through the right superior pulmonary vein.Using sterile technique, the catheter was pulled from the chest.During the removal of the catheter, the tip broke off somewhere in the skin/soft tissue, as reported by dr.(b)(6).

• Brand Name: MIKRO-CATH PRESSURE CATHETER
• Type of Device: MIKRO-CATH
• Manufacturer (Section D): MILLAR INC.; 6001-a gulf freeway; houston TX 77023
• Manufacturer (Section G): MILLAR INC.; 6001-a gulf freeway; houston TX 77023
• Manufacturer Contact: jacqueline jean-baptiste ; 6001-a gulf freeway; houston, tx ; 6677131
• MDR Report Key: 5975010
• MDR Text Key: 55909019
• Report Number: 1625382-2016-00001
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2016

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: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: 825-0101
• Device Catalogue Number: 802-0101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2016
• 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 Age: 36 YR
• Patient Weight: 126