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

Model Number	IBI-81594
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial tachycardia ablation procedure, the catheter was difficult to pull back out of the sheath.Upon removal, the catheter was noted to be fractured between electrodes 4 and 5.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Event or Problem Description
Manufacturer reference number: 3005334138-2022-00334.
Additional Manufacturer Narrative
One decapolar, spiral loop, inquiry afocusii diagnostic catheter was received for evaluation.The reported withdrawal difficulty was confirmed.The catheter straightener was passed over the loop and was unable to pass over electrode ring 5 due to the foreign material.A white foreign material was noted under electrode ring 5, preventing the straightener from completely passing over the loop, consistent with the reported withdrawal difficulty.The fm and a stock fast-cath introducer were sent for s&t analysis.The ftir spectrum for the two materials were a match.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fm under electrode ring 5 is 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; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13360512
• Report Number: 2030404-2022-00004
• Device Sequence Number: 1674725
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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: 02/29/2024
• Device Model Number: IBI-81594
• Device Catalogue Number: IBI-81594
• Device Lot Number: 7885726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FAST-CATH TRANSSEPTAL GUIDING INTRODUCER, SL1 8.5F
• Patient Sex: Unknown