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	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
During an atrial tachycardia procedure, the catheter became lodged in the patient and could not be removed.Following mapping in the right atrium, fluoroscopy revealed the catheter would not move and could not be removed from the inferior cava.A tee did not determine where the catheter was located, and the patient was transferred to surgery to extract the catheter via the subclavian vein.The patient is recovering in the uci.
Event or Problem Description
It is possible that the device was trapped in fibers between the inferior vena cava and the lateral wall.

• 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: 8623564
• Report Number: 2030404-2019-00035
• Device Sequence Number: 2257316
• Product Code: DRF
• UDI-Device Identifier: 05414734309929
• UDI-Public: 05414734309929
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: IBI-87008
• Device Lot Number: 6602300
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Weight: 68