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	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results will be provided in a subsequent submission. .
Event or Problem Description
During the procedure, the afocus catheter loop became entangled around the introducer while in the left atrium.The ablation catheter was used to pull on the afocus and retract it at the same time.There were no adverse consequences for the patient.
Event or Problem Description
During the procedure, the afocus catheter loop became entangled around the introducer while in the left atrium.The ablation catheter was used to pull on the afocus and retract it at the same time.The catheter was replaced and the procedure was completed with no adverse consequences for the patient.
Additional Manufacturer Narrative
One inquiry afocusii¿ (4 f double loop) catheter 20 electrode, 7f was returned for investigation.The reported entanglement of the catheter loop could not be confirmed, however a bend in the shaft and twisted shaft material was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bent shaft, and twisted shaft material and subsequent catheter entanglement 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: 9457294
• Report Number: 2030404-2019-00117
• Device Sequence Number: 3103957
• Product Code: DRF
• UDI-Device Identifier: 05414734309929
• UDI-Public: 05414734309929
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2020

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: 04/30/2022
• Device Model Number: IBI-87008
• Device Catalogue Number: IBI-87008
• Device Lot Number: 6975399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019; 01/31/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 12/19/2019; 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1