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

Model Number	IBI-81107
Medical Device Problem Codes	Material Frayed (1262); Difficult to Insert (1316)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, difficulties placing the catheter in the coronary vein were noted and when removing the catheter from the patient, exposed wires were noted near the tip of the catheter.The device was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One decapolar, inquiry steerable diagnostic catheter was received for evaluation.A bend was noted in the catheter shaft however, the catheter shaft deflected when actuating the steering mechanism and deflected in the correct shape according to specifications.The catheter had no fractured tip, no exposed wires, or damage to the tip of the catheter; however, foreign material that was noted to be biological material was found on the tip of the catheter.The catheter was inserted and removed from a stock introducer with no anomalies.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported "exposed wires", placement difficulty, and removal difficulty remain unknown.The cause of the bend is consistent with damage during use.Overall, no malfunction occurred that did, or would likely, cause or contribute to a serious injury or death.

• Brand Name: INQUIRY STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: 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: 11497495
• Report Number: 3008452825-2021-00144
• Device Sequence Number: 4602301
• Product Code: DRF
• UDI-Device Identifier: 05414734303002
• UDI-Public: 05414734303002
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/10/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: IBI-81107
• Device Catalogue Number: IBI-81107
• Device Lot Number: 7685371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1