MAUDE Adverse Event Report: ST. JUDE MEDICAL INQUIRY¿ ELECTROPHYSIOLOGY STEERABLE CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-81402
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, the catheter was positioned in the corresponding heart area without difficulty.At the time of withdrawal, a fracture was noted on the catheter.
Event or Problem Description
During a supraventricular tachycardia procedure, the catheter was positioned in the corresponding heart area without difficulty.At the time of withdrawal, a fracture was noted on the catheter.The device was exchanged, and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d4, d9, g1, g3, h2, h3, h6, h11.One quadripolar, inquiry steerable diagnostic catheter was received for evaluation.A bend in the catheter shaft was noted at 3.0¿ proximal to the distal tip.The catheter shaft was also noted to be twisted.No fractures were noted or exposed components were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bend and twisted catheter shaft remains unknown.

• Brand Name: INQUIRY¿ ELECTROPHYSIOLOGY STEERABLE CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19564317
• Report Number: 2030404-2024-00039
• Device Sequence Number: 6948593
• Product Code: DRF
• UDI-Device Identifier: 05414734304122
• UDI-Public: (01)05414734304122(10)10169237(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K961924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2024

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 Model Number: IBI-81402
• Device Catalogue Number: IBI-81402
• Device Lot Number: 10169237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 07/23/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/10/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown