MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number	D128210
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old male patient underwent an paroxysmal atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that prior to ablation, during mapping in the left atrium with the pentaray, anesthesia personnel noted hypotension.Using fluoro imaging, they noted that the heart border was not moving as normal.Ice (intracardiac echocardiography) was used to check the heart, and a pericardial effusion was noted.Pericardiocentesis was performed, and fluid amount withdrawn is unknown as it was auto-transfused back to the patient.This adverse event was discovered during use of bwi products.The physician¿s opinion on the cause of this adverse event is unknown.The patient outcome of the adverse event is stable.The patient did require extended hospitalization because of the adverse event.Two transseptal punctures were performed with a cook needle.Ablation was not performed prior to noting the pericardial effusion.There was no evidence of steam pop as no ablation was performed.The event occurred during mapping.No error messages were observed on biosense webster equipment during the procedure.The patient is hemodynamically stable at this time.The effusion was discovered with ice imaging after hypotension.The patient was admitted.Suspected perforation is unknown.It was confirmed with soundstar.Pericardiocentesis was performed.The tube was left in place.The procedure was abandoned.There was no evidence of any effusion present before the procedure.No ablation was performed so ablation catheter not opened.The physician¿s opinion on the cause of this adverse event reason is unknown.It could be due to anatomical structure.A pericardiocentesis was performed and the patient outcome of the adverse event was fully recovered.Since the event is life threatening and required intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.
Additional Manufacturer Narrative
On 12-aug-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a 76-year-old male patient underwent an paroxysmal atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the pentaray nav eco catheter.Per the event, several tests were performed.The magnetic features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device number 30713668l, and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.The instructions for use (ifu) 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 device 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: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14984015
• Report Number: 2029046-2022-01577
• Device Sequence Number: 12048466
• Product Code: MTD
• UDI-Device Identifier: 10846835012248
• UDI-Public: 10846835012248
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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: 01/06/2025
• Device Model Number: D128210
• Device Catalogue Number: D128210
• Device Lot Number: 30713668L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• 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 CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male