MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY AFOCUSII¿ (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-87008
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One duodecapolar, double loop, inquiry afocusii diagnostic catheter was received for evaluation.No blood-like substance (bls) was noted on the returned device.A bend and kinks in the catheter shaft were noted proximal to the spiral loop/shaft transition.A tear in the catheter shaft with protruding braided wires was also noted proximal to the spiral loop/shaft transition.No other visual anomalies were noted.The catheter deflected when actuating the steering mechanism; however, the catheter did not deflect in the correct shape according to specifications, due to bends and tear in the shaft.The investigation concluded that the cause of the damaged and kinked shaft was due to the catheter being over torqued during use.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the damaged and kinked shaft is consistent with damage during use.
Event or Problem Description
This report is to advise of an event observed during analysis confirming a tear in the catheter shaft.

• Brand Name: INQUIRY AFOCUSII¿ (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F
• 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: 8564497
• Report Number: 2030404-2019-00029
• Device Sequence Number: 2074929
• Product Code: DRF
• UDI-Device Identifier: 05414734309929
• UDI-Public: 05414734309929
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K101623
• 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): 04/30/2019

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: 05/31/2021
• Device Model Number: IBI-87008
• Device Lot Number: 6520728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1