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	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of the device, a fractured and detached electrode was noted.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
This report is to advise of an event observed upon receipt of the device revealing a fractured and detached electrode.
Additional Manufacturer Narrative
One decapolar, spiral loop, inquiry afocusii diagnostic catheter was received for evaluation.Visual inspection revealed the distal electrode was fractured and detached from the spiral loop.The distal electrode was not returned.In addition, the spiral loop was stretched and flattened.The catheter shaft met specifications for outer diameter, however due to the condition of the returned device, functional testing could not be performed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured and detached tip electrode and the reported insertion difficulty is consistent with not using the tip straightener to straighten the loop during insertion of the catheter into the introducer sheath.Per the ifu, pulling the thumb control straightens the catheter shaft.Always make sure to pull the thumb control downward completely before removing the catheter from the patient.

• 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: 8531027
• Report Number: 2030404-2019-00025
• Device Sequence Number: 11082167
• 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
• Report Date (Section B): 06/18/2019

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: 06/30/2021
• Device Model Number: D087023
• Device Lot Number: 6548546
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1