MAUDE Adverse Event Report: ST. JUDE MEDICAL INQUIRY ELECTROPHYSIOLOGY CATHETER, INQUIRY AFOCUS II EB CATHETER, 110 CM LEN; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D087023
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation (af) procedure, blood was dripping out of the catheter handle.The catheter was removed and it was noted that the braiding at the distal end of the catheter was damaged.The catheter was replaced and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: INQUIRY ELECTROPHYSIOLOGY CATHETER, INQUIRY AFOCUS II EB CATHETER, 110 CM LEN
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• MDR Report Key: 12324147
• Report Number: 2030404-2021-00047
• Device Sequence Number: 4301349
• Product Code: DRF
• UDI-Device Identifier: 05414734311434
• UDI-Public: 05414734311434
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K010471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 03/31/2024
• Device Model Number: D087023
• Device Catalogue Number: D087023
• Device Lot Number: 7924245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1