MAUDE Adverse Event Report: ST. JUDE MEDICAL INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number IBI-81104

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 12/05/2018

Event Type  Injury  

Event Description

Related manufacturer reference: 9680001-2018-00189.During a premature ventricular contraction / ventricular tachycardia ablation procedure, a pericardial effusion occurred.Following catheter manipulation and ablation in the coronary sinus, the patient became hypotensive.An intracardiac ultrasound confirmed a pericardial effusion, for which a pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device during the procedure.

Manufacturer Narrative

The catheter met specifications for electrical and temperature testing, and met acceptable irrigation rates during a flow test.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported pericardial effusion remains unknown as it could not be confirmed.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8192083
• MDR Text Key: 131299660
• Report Number: 3008452825-2018-00446
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734302975
• UDI-Public: 05414734302975
• Combination Product (y/n): N
• PMA/PMN Number: K961924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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: 09/30/2021
• Device Model Number: IBI-81104
• Device Catalogue Number: IBI-81104
• Device Lot Number: 6673584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER
• Patient Outcome(s): Other
• Patient Age: 78 YR