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

Model Number	IBI-81104
Medical Device Problem Codes	Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, the catheter did not keep its curve and a delay occurred.A new catheter was opened and manipulated, however the physician preferred the feel of the first catheter.Therefore, the first catheter inserted again and was not able to advance into the coronary sinus.A livewire catheter was then used to complete the procedure with no consequences to the patient.
Additional Manufacturer Narrative
One decapolar, inquiry steerable diagnostic catheter was received for evaluation.The catheter was found to have the handle cap partially unscrewed.Once tightened, the catheter deflected when actuating the steering mechanism, and deflected in the correct shape according to specifications.The catheter was then able to maintain its curve upon release of the steering mechanism.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported deflection issue and subsequent delay was due to the handle cap being partially unscrewed.The cause for the position of the handle cap remains unknown.

• Brand Name: INQUIRY STEERABLE DIAGNOSTIC CATHETER
• 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: 12447249
• Report Number: 2030404-2021-00057
• Device Sequence Number: 4381656
• Product Code: DRF
• UDI-Device Identifier: 05414734302975
• UDI-Public: 05414734302975
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/17/2021

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: 05/31/2024
• Device Model Number: IBI-81104
• Device Catalogue Number: IBI-81104
• Device Lot Number: 8003081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1