MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NOGA-STAR CARDIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 120708S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Event Description

Initially the patient event was only reported under the thermocool® smart touch® sf bi-directional navigation catheter as the noga-star¿ cardiology catheter was assessed as a concomitant product.After additional review on november 22, 2019, since the event was discovered during use of thermocool® smart touch® sf bi-directional navigation catheter and after the use of the noga-star¿ cardiology catheter, the event will be conservatively reported under both devices.The re-assessment awareness date for the noga-star¿ cardiology catheter reportable determination was november 22, 2019.It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a noga-star¿ cardiology catheter and developed vessel perforation.During the procedure, during use of thermocool® smart touch® sf bi-directional navigation catheter and after use of the noga-star¿ cardiology catheter, an aortic dissection was noticed.First retrograde access was successful with the noga-star¿ cardiology catheter.No needle was deployed.The physician was not able to gain access the second time with the thermocool® smart touch® sf bi-directional navigation catheter, for retrograde arterial access.The aortic dissection was confirmed by an aortogram with dye.No medical intervention was needed.Procedure successfully completed.The patient was reported to be in stable condition and their condition has improved.Patient was monitored overnight and released.The ablation was performed with the thermocool® smart touch® sf bi-directional navigation catheter.A non biosense webster sheath was used during the procedure.Physician stated he did not think issue or complication was catheter related.The physician¿s opinion on the cause of the adverse event is procedure related and patient condition related.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a noga-star¿ cardiology catheter.During the procedure, during use of thermocool® smart touch® sf bi-directional navigation catheter and after use of the noga-star¿ cardiology catheter, an aortic dissection was noticed.First retrograde access was successful with the noga-star¿ cardiology catheter.No needle was deployed.The physician was not able to gain access the second time with the thermocool® smart touch® sf bi-directional navigation catheter, for retrograde arterial access.The aortic dissection was confirmed by an aortogram with dye.No medical intervention was needed.Procedure successfully completed.The patient was reported to be in stable condition and their condition has improved.Patient was monitored overnight and released.The ablation was performed with the thermocool® smart touch® sf bi-directional navigation catheter.A non biosense webster sheath was used during the procedure.Physician stated he did not think issue or complication was catheter related.The device was visually inspected and it was found in good condition.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, deflection test was performed and it was found within specifications, the catheter was deflecting correctly.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.A manufacturing record evaluation was performed for the finished device 30139388m number, and no internal action was found during the review.The customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: NOGA-STAR CARDIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9470317
• MDR Text Key: 182586882
• Report Number: 2029046-2019-03993
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835002058
• UDI-Public: 10846835002058
• Combination Product (y/n): N
• PMA/PMN Number: K954390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: 120708S
• Device Catalogue Number: 120708S
• Device Lot Number: 30139388M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON-BWI UNKNOWN BRAND SHEATH; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Life Threatening