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

Model Number IBI-81104

Device Problems Communication or Transmission Problem (2896); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in a subsequent submission.

Event Description

During an atrial fibrillation ablation procedure a cancellation occurred.While using the catheter as a positional reference during the case the catheter was difficult to handle, there was intermittent signal loss and a geometry shift.The catheter was exchanged and confirmed as bent when removed from the patient.After catheter replacement the user decided to end the procedure due to time constraints.The procedure was cancelled and the patient is stable.

Manufacturer Narrative

One inquiry steerable diagnostic catheter was received for evaluation.The catheter created an ¿s¿ shaped curve during deflection, which no longer matched the required curve template.Electrodes 1-10 met specifications of acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause for an ¿s¿ shaped curve is due to the activation wire shifting over the flat wire.The root cause for the reported signal loss could not be confirmed.

Event Description

The procedure was a ventricular tachycardia ablation.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 8771350
• MDR Text Key: 150399703
• Report Number: 3008452825-2019-00322
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: IBI-81104
• Device Catalogue Number: IBI-81104
• Device Lot Number: 6962899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other