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

Model Number	IBI-81104
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At the end of an atrial fibrillation procedure, it was not possible to retract the advisor hd grid and inquiry decapolar catheter from the femoral vein.An xray image indicated the inquiry decapolar catheter was wrapped around advisor hd grid catheter.A vascular physician assisted with removal of the catheters by cutting the entry point so that it was bigger.There were no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One decapolar, inquiry steerable diagnostic catheter was received for evaluation.The shaft was found damaged.The shaft of the catheter was found bent in multiple locations.No other visual anomalies were noted.The damage is consistent with using force to withdraw the product when resistance is encountered.The product instructions for use (ifu) warns do not use force to advance or withdraw catheter when resistance is encountered.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the device entanglement is consistent with not following the instructions for use.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20065183
• Report Number: 3008452825-2024-00457
• Device Sequence Number: 15618852
• Product Code: DRF
• UDI-Device Identifier: 05414734302975
• UDI-Public: (01)05414734302975(10)10291340(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 09/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: IBI-81104
• Device Catalogue Number: IBI-81104
• Device Lot Number: 10291340
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR¿ HD GRID MAPPING CATHETER, SE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown