MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number	D160902
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure, with an octaray, galaxy, 48p, 2-5-2-5-2, d-curve and an unknown smart touch bidirectional sf and suffered cardiac tamponade requiring a pericardiocentesis and prolonged hospitalization.A cardiac tamponade was discovered about four hours after the procedure.The cardiac tamponade was discovered by the hospital staff later in the day and was confirmed by ultrasound.The medical intervention provided was a pericardiocentesis and 400cc of fluid were removed.The patient was reported to be in stable condition.A smart touch surround flow (stsf) catheter was used in the case for ablation.The physician is uncertain of the cause of the tamponade.The physician had a potential concern that it was related to octaray catheter.The patient has improved but required extended hospital stay and rehab and has fully recovered.The generator used in the case was a smart ablate and a brk xs (model unavailable) was used for transseptal puncture.Prior to noting the cardiac tamponade, ablation was performed.The physician thought a steam pop could have occurred but no effusion after and no associated temperature or impedance rise was noticed.An irrigated catheter was used in the event and the flow setting was set to standard flow settings for stsf (15 ml/min).The correct catheter settings were selected on the irrigation pump and the pump was switching from low to high flow during irrigation.No error messages were observed on biosense webster equipment during the procedure.The catheter was disposed of before adverse event was reported; therefore, they are not available to return for investigation.Conservatively this will be reported on both octaray, galaxy, 48p, 2-5-2-5-2, d-curve and an unknown smart touch bidirectional sf as the physician was concerned that the cardiac tamponade was caused by the octaray and ablation was performed and completed so the ablation catheter will be reporter on as well.Should more information become available, it will be reviewed and processed accordingly.
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number pc-001064372 has two reports: mfr # 2029046-2022-00417 for product code d160902 (octa,galaxy,2-5-2-5-2,d-curve).Mfr # 2029046-2022-00418 for product code unk (thermocool® smart touch® sf bi-directional navigation catheter).

• Brand Name: OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13636706
• Report Number: 2029046-2022-00417
• Device Sequence Number: 5201350
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K193237
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

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 Model Number: D160902
• Device Catalogue Number: D160902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: SMARTABLATE GENERATOR KIT-US; UNK BRK XS NEEDLE; UNK_SMART TOUCH BIDIRECTIONAL SF
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male