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

Model Number	IBI-81104
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During a focal atrial tachycardia ablation procedure, the catheter was noted to become stuck at the coronary sinus ostium and was thought to have removed a piece of heart tissue when finally removing the catheter.The catheter was able to be removed without any intervention.The catheter was replaced and the procedure was able to be completed.The patient experienced chest pain following the procedure, but was noted to be stable.No pericardial effusion was noted on echocardiogram.
Additional Manufacturer Narrative
One decapolar, inquiry steerable diagnostic catheter was received for evaluation.No visual anomalies were noted.The catheter shaft deflected when actuating the steering mechanism and deflected in the correct shape according to specifications, additionally the outer diameter of the catheter shaft met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the removal difficulty and suspect removal of heart tissue remains unknown.

• Brand Name: INQUIRY STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• MDR Report Key: 11979057
• Report Number: 2030404-2021-00037
• Device Sequence Number: 19751397
• Product Code: DRF
• UDI-Device Identifier: 05414734302975
• UDI-Public: 05414734302975
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: IBI-81104
• Device Catalogue Number: IBI-81104
• Device Lot Number: 7854717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other