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	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results will be provided in the final report.Further information regarding the event was requested but not received.
Event or Problem Description
During a procedure, when the catheter was being removed from the introducer, the catheter tip became detached.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One decapolar, inquiry steerable diagnostic catheter was received for evaluation.The catheter shaft was received wrapped tightly in a coil around the handle, causing bends in the catheter shaft.Electrodes 2-10 met specifications of acceptable resistance values with no open or short circuits detected.Functional testing could not be performed on the distal electrode due to the condition of the returned catheter.Further investigation revealed that that the tip electrode was detached from the catheter shaft, which is consistent with the reported display issue.The device met specifications prior to leaving abbott manufacturing facilities as supported by a review of the device history record.Based on the received condition of the device and the information provided, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Additional information received indicated that the electrode becoming detached occurred outside of the patient and therefore no intervention was required.

• 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: 8961438
• Report Number: 2030404-2019-00088
• Device Sequence Number: 3146872
• Product Code: DRF
• UDI-Device Identifier: 05414734311434
• UDI-Public: 05414734311434
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042775
• 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,Followup
• Report Date (Section B): 09/20/2019

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: 12/31/2021
• Device Model Number: D087023
• Device Lot Number: 6794075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/10/2019; 09/20/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/17/2019; 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other