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

Model Number	IBI-81530
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One decapolar, inquiry steerable diagnostic catheter was received for evaluation.The catheter deflected when actuating the steering mechanism; however, the catheter did not deflect in the correct shape according to specifications, due to a kink in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the kink is consistent with damage during use.
Event or Problem Description
Following a successful premature ventricular contractions (pvc) procedure, worsening of a baseline pericardial effusion occurred.At the end of the procedure, as the catheter was removed, there was difficulty, and a kink and possible fracture was noted proximal to the last electrode.Following the procedure, while monitoring the baseline effusion via ice and echo, it was noted to have worsened and a pericardiocentesis was performed and 800 ml/fluid was removed.The physician alleges the worsening of the effusion was likely due to difficulty removing the catheter.The patient is currently in stable condition and has been discharged.

• 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: 12245099
• Report Number: 3008452825-2021-00377
• Device Sequence Number: 19927786
• Product Code: DRF
• UDI-Device Identifier: 05414734304771
• UDI-Public: 05414734304771
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

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: 12/31/2023
• Device Model Number: IBI-81530
• Device Catalogue Number: IBI-81530
• Device Lot Number: 7784833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/29/2021
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 110