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

Model Number	825-0101-5
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The inital evaluation showed the there was some stress on teh catheter at teh point of the break.Teh internal wires are broken, and imaging taken at millar of these wires indicates that they have been stretched before breaking at the teh point where teh catheter was marked with a sharpie.It is our understanding that this is the point where the hemostasis valve was placed and tightened to secure the mikro-cath in place.Th epoint of the break shows stress.
Event or Problem Description
The catheter broke in teh patients body after the physician pulled the catheter back to the ao.The catheter was pulled back just a little bit and the tip did not pull back as the catheter was pulled back.It was observed the millar catheter was broken at approximately 15 cm from the end.Pinched guide catheter and pulled all out easily with no resistance.

• Brand Name: MIKRO-CATH PRESSURE CATHETER
• Common Device Name: PRESSURE TRANSDUCER
• Manufacturer (Section D): MILLAR INC.; 6001-a gulf freeway; houston TX 77023
• Manufacturer (Section G): MILLAR LLC; 6001-a gulf freeway; houston 77023
• Manufacturer Contact: jacqueline jean-baptiste ; 6001-a gulf freeway; houston, TX 77023 ; 8326677100
• MDR Report Key: 13957339
• Report Number: 1625838-2022-00001
• Device Sequence Number: 12002168
• Product Code: DXO
• UDI-Device Identifier: 00868924000205
• UDI-Public: (01)00868924000205(10)58713(17)230720
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2023
• Device Model Number: 825-0101-5
• Device Catalogue Number: 825-0101-5
• Device Lot Number: 58713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White