MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY AFOCUS LL DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-81594
Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the catheter became stuck in the sl1 sheath.The catheter was carefully removed, but was fractured with exposed wires.The catheter was exchanged to continue the procedure with no consequence to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3 one decapolar, spiral loop, inquiry afocusii diagnostic catheter was received for evaluation.Visual inspection revealed the distal tip was noted to be fractured and detached exposing the conductor wires.Electrodes 2-3 were also noted to be displaced.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured and detached distal tip and displaced electrodes are consistent with damage during use.

• Brand Name: INQUIRY AFOCUS LL DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 12211442
• Report Number: 2030404-2021-00046
• Device Sequence Number: 6107778
• Product Code: DRF
• UDI-Device Identifier: 05414734305006
• UDI-Public: 05414734305006
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/04/2021

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: 11/30/2023
• Device Model Number: IBI-81594
• Device Catalogue Number: IBI-81594
• Device Lot Number: 7764435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1