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

Model Number IBI-81871

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 09/17/2021

Event Type  malfunction  

Event Description

Manufacturer report number: 3008452825-2021-00489.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.

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
• Type of Device: 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: 12638753
• MDR Text Key: 276588619
• Report Number: 3008452825-2021-00490
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734306034
• UDI-Public: 05414734306034
• 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: 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
• Device Operator: 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 Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INQUIRY CATHETER; INQUIRY CATHETER