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 Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation procedure the catheter was difficult to pull back into the sheath after mapping had been performed.Once removed the catheter coating was noted to be deteriorated/cut.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One duodecapolar, double loop, inquiry afocusii diagnostic catheter was received for evaluation.The catheter shaft was twisted and torn exposing the spring body, consistent with the reported damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the shaft damage is consistent with damage during use.

• 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: 8517735
• Report Number: 2030404-2019-00022
• Device Sequence Number: 1629213
• Product Code: DRF
• UDI-Device Identifier: 05414734309929
• UDI-Public: 05414734309929
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 06/07/2019

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: 10/31/2021
• Device Model Number: IBI-87008
• Device Lot Number: 6727591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1