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

Model Number	IBI-81871
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer report number: 3008452825-2021-00490.During an supraventricular tachycardia (svt) procedure, it was noted that the catheter was not deflecting as expected.The catheter was exchanged but this issue persisted with the second catheter.The catheter was replaced with a third catheter from a different batch and the procedure was completed with no adverse consequences to the patient.A procedure delay occurred due to these issues.
Additional Manufacturer Narrative
One 8-pole, inquiry steerable diagnostic catheter was received for evaluation.The catheter shaft deflected when actuating the steering mechanism and deflected in the correct shape according to specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the deflection issue remains unknown.

• 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
• MDR Report Key: 12638746
• Report Number: 3008452825-2021-00489
• Device Sequence Number: 13754417
• Product Code: DRF
• UDI-Device Identifier: 05414734306034
• UDI-Public: 05414734306034
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 03/31/2024
• Device Model Number: IBI-81871
• Device Catalogue Number: IBI-81871
• Device Lot Number: 7949839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INQUIRY CATHETER.; INQUIRY CATHETER.