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

Model Number IBI-81104

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 12447249
• MDR Text Key: 270626776
• Report Number: 2030404-2021-00057
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734302975
• UDI-Public: 05414734302975
• Combination Product (y/n): N
• PMA/PMN Number: K961924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1