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

Model Number	IBI-81531
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During a right ventricular outflow tract procedure, a pericardial effusion occurred.Following difficulty advancing the catheter during coronary sinus cannulation, the catheter appeared to buckle under x-ray.Resistance was noted when attempting to remove the catheter.After applying traction force the catheter dislodged and was withdrawn.A bend was noted at the proximal electrodes when the device was removed.The patient remained stable for the remainder of the procedure, however became hypotensive following the procedure.An electrocardiogram confirmed a pericardial effusion around the right ventricle.The effusion resolved without intervention and the patient was in a stable condition.It was indicated the effusion may have occurred due to the catheter not steering as expected and being entangled in the patients anatomy, leading to withdrawal difficulty and subsequent pericardial effusion.
Additional Manufacturer Narrative
One inquiry ¿ steerable diagnostic catheter was received for investigation.The catheter deflected when actuating the steering mechanism; however, the catheter did not deflect in the correct shape according to specifications, due to a bend in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bend is consistent with damage during use.The cause of the pericardial effusion remains unknown as it could not be confirmed.

• 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: 8488174
• Report Number: 3008452825-2019-00139
• Device Sequence Number: 14142879
• Product Code: DRF
• UDI-Device Identifier: 05414734304788
• UDI-Public: 05414734304788
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K961924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 09/30/2021
• Device Model Number: IBI-81531
• Device Catalogue Number: IBI-81531
• Device Lot Number: 6701555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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