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

Model Number	120708S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction (pvc) / ischemic ventricular tachycardia (isvt) ablation procedure with a noga-star¿ cardiology catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported that during a pvc/ventricular tachycardia ischemic case, a pericardial effusion was noticed.The pericardial effusion was discovered by intracardiac echocardiography (ice).It was confirmed by ice with the soundstar eco catheter.The medical intervention provided was a pericardiocentesis (in progress at the time of the call) and it was unknown how much fluid was removed.The patient went back to the recovery unit.They brought him back later to perform another pericardiocentesis because the effusion re-accumulated.There were no details about patient requiring extended hospitalization.It was reported that the patient went to the intensive care unit (icu).The patient was reported to be in stable condition.It was unknown what caused the pericardial effusion.It was reported that the ablation catheter never entered the patient¿s body.This adverse event was discovered during use of biosense webster products.The physician did not provide a causality opinion for the cause of this adverse event.No transseptal puncture was performed.Prior to noting the ct, ablation was not performed.There was no evidence of a steam pop.
Additional Manufacturer Narrative
The biosense webster, inc.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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The device evaluation was completed on 19-nov-2021.It was reported that a patient underwent a premature ventricular contraction (pvc) / ischemic ventricular tachycardia (isvt) ablation procedure with a noga-star¿ cardiology catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported that during a pvc/ventricular tachycardia ischemic case, a pericardial effusion was noticed.The pericardial effusion was discovered by intracardiac echocardiography (ice).It was confirmed by ice with the soundstar eco catheter.The medical intervention provided was a pericardiocentesis (in progress at the time of the call) and it was unknown how much fluid was removed.The patient went back to the recovery unit.They brought him back later to perform another pericardiocentesis because the effusion re-accumulated.There were no details about patient requiring extended hospitalization.It was reported that the patient went to the intensive care unit (icu).The patient was reported to be in stable condition.It was unknown what caused the pericardial effusion.It was reported that the ablation catheter never entered the patient¿s body.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned product revealed that no damage or anomalies were observed on the noga-star¿ cardiology catheter.Per the event, several tests were performed.The magnetic feature was tested, and no issues were observed.In addition, the product was deflecting correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30418871m number, and no internal action related to the complaint was found during the review.As part of bwi¿s quality process, all catheters are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instruction for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the catheter that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: NOGA-STAR¿ CARDIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12637972
• Report Number: 2029046-2021-01764
• Device Sequence Number: 11675259
• Product Code: DRF
• UDI-Device Identifier: 10846835002058
• UDI-Public: 10846835002058
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K954390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2021

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: 08/04/2023
• Device Model Number: 120708S
• Device Catalogue Number: 120708S
• Device Lot Number: 30418871M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 10/26/2021; 11/19/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/02/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOUNDSTAR ECO GE 10F CATHETER; UNK_SMART TOUCH BIDIRECTIONAL SF
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown