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

Model Number 825-0101

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

The device was implanted for greater than the 24 hours as specified by the ifu.The doctor also failed to use a guidewire as recommended in the ifu.

Event Description

The surgical team's physician assistant attempted to remove the catheter from the patient by pulling the catheter from the chest wall at the bed side.The physician assistant felt resistance while attempting to pull the catheter out at the end of the procedure.The doctor (implanting physician) met with the patient and they decided to cut the catheter lead at the skin site.It has not been confirmed how much of the catheter length was left in the patient.Per the doctor, he believes the catheter tip and remaining length is located in the chest outside of the heart.

• Brand Name: MIKRO-CATH
• Type of Device: MIKRO-CATH PRESSURE TRANSDUCER CATHETER
• 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 77023 ; 8326677131
• MDR Report Key: 11632116
• MDR Text Key: 268487917
• Report Number: 1625382-2017-00002
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2017

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: 01/13/2019
• Device Model Number: 825-0101
• Device Catalogue Number: 825-0101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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): Other
• Patient Age: 71 YR
• Patient Weight: 59