MAUDE Adverse Event Report: MILLAR INC. MIKRO-CATH; PRESSURE TRANSDUCER CATHETER, PRODUCT CODE DXO

Model Number 825-0101

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/26/2017

Event Type  malfunction  

Event Description

The surgical team's physician assistants attempted to remove the mikro-cath from the patient by pulling the catheter from the chest wall at bedside.They physician assistant felt resistance while attempting to pull the catheters out and ended the procedure.The doctor met with the patient and decided to cut the catheter lead at the skin site.It is unsure how much catheter has been left in the patient.The physician believes the catheter tip and remaining length is located in the chest outside the heart.

• Brand Name: MIKRO-CATH
• Type of Device: PRESSURE TRANSDUCER CATHETER, PRODUCT CODE DXO
• Manufacturer (Section D): MILLAR INC.; 6001-a gulf freeway; houston TX 77023 8498
• 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: 11632115
• MDR Text Key: 246270982
• Report Number: 1625382-2017-00001
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2017

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
• Device Lot Number: 38554
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 90