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

Model Number	IBI-81594
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	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One inquiry afocusii catheter was received for evaluation.Visual inspection revealed electrodes 3-4, and 6 were displaced from their original location.A kink was noted at the spiral loop/shaft transition.Bends in the catheter shaft were noted 1.40¿ and 5.60¿ proximal to the spiral loop/shaft transition.Electrode rings 3-4, and 6 were noted to be distally displaced from their original location and had been fractured at the weld joint, consistent with the open circuits detected and the reported signal issue.Dissection revealed conductor wires 8-10 had been fractured proximal to the weld joint.Electrodes 1-2, 5, and 7 met specifications of acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the distally displaced electrode rings, and fractured conductor wires is consistent with damage during use.
Event or Problem Description
This report is to advise of an event observed upon receipt showing displaced electrodes.

• Brand Name: INQUIRY¿ AFOCUS LL¿ DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 7877056
• Report Number: 2030404-2018-00066
• Device Sequence Number: 182244
• Product Code: DRF
• UDI-Device Identifier: 05414734305006
• UDI-Public: 05414734305006
• 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
• Report Date (Section B): 09/14/2018

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: 07/31/2019
• Device Model Number: IBI-81594
• Device Lot Number: 5592336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1