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

Model Number IBI-81104

Device Problems Break (1069); Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)

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

Event Date 03/04/2021

Event Type  malfunction  

Event Description

During a ventricular tachycardia ablation procedure, at the beginning of the procedure the catheter became trapped in the cavotricuspid isthmus near the inferior vena cava and had to be removed with a metal ribbon.The catheter was not able to be removed by deflecting it and eventually the catheter stopped deflecting.The catheter was then cut near the handle in order to pass a long sheath along it in an attempt to remove the catheter.The catheter remained trapped and had to be taken out by using an additional retrieval instrument.The procedure was cancelled due to the issue.The patient was noted to be stable.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6 the distal 5¿ of a decapolar, inquiry steerable diagnostic catheter shaft was received for evaluation.The rest of the catheter was not received.The cause of the deflection issue was unable to be confirmed due to the condition of the returned device.The catheter shaft was fractured and detached and electrodes 2 and 5-10 were displaced.Functional testing was not possible due to the aforementioned damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the deflection issue remains unknown.The cause of the damage, displaced electrodes, and withdrawal difficulty are consistent with damage during use.

• 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: 11563682
• MDR Text Key: 242391004
• Report Number: 3008452825-2021-00143
• 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: 06/15/2021

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: 09/30/2023
• Device Model Number: IBI-81104
• Device Catalogue Number: IBI-81104
• Device Lot Number: 7688896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1