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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
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 an atrial fibrillation procedure, the tip electrode detached from the catheter.The catheter was difficult to insert and became lodged within the introducer.Upon removal of the catheter from the introducer, the electrode was noted to be detached.The catheter and introducer were exchanged and the procedure completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d10, g4, h2, h3, h6.One decapolar, spiral loop, inquiry afocusii diagnostic catheter was received for evaluation.One image was also submitted for evaluation.The photograph appeared to show a detached distal tip electrode.Visual inspection of the returned catheter confirmed that the catheter tip was separated from the catheter blue shaft tip.Microscopic investigation revealed the catheter blue shaft tip was damaged and torn.The loop forming nitinol wire loop was detached and missing.The assembled conductor wire at the blue shaft tip was not visible, it was also separated with the tip electrode.The microscopic view of the blue shaft revealed the tip was stretched.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detached tip electrode 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: 10118338
• Report Number: 2030404-2020-00041
• Device Sequence Number: 2143022
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 05/31/2022
• Device Model Number: D087023
• Device Catalogue Number: D087023
• Device Lot Number: 7061569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1