MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
During atrial fibrillation ablation procedure, the electrode of the catheter fractured within the introducer sheath.The catheter and sheath were removed together and the procedure was completed with no consequences to the patient.
Additional Manufacturer Narrative
One decapolar, spiral loop, inquiry afocusii diagnostic catheter was received for evaluation.Visual inspection revealed the catheter tip was fractured and lodge in the returned introducer.Additional investigation revealed the introducer sheath was not properly used, and the catheter tip was lodged in the introducer sheath.When trying to remove the lodged tip from the introducer sheath, extra force was applied to the catheter.As a result, the catheter tip was separated from the catheter shaft assembly.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured shaft is consistent with damage during use.

• 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, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 10560439
• Report Number: 2030404-2020-00077
• Device Sequence Number: 2977608
• Product Code: DRF
• UDI-Device Identifier: 05414734311434
• UDI-Public: 05414734311434
• 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): 02/02/2021

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: 08/31/2022
• Device Model Number: D087023
• Device Catalogue Number: D087023
• Device Lot Number: 7193238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1