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

Model Number D128208

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

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number pc-000786754 has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6) male patient with history of prior atrial fibrillation (afib) ablation procedure, left ventricle dysfunction and amiodarone, underwent an afib ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and pentaray nav high-density mapping eco catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.Pericardial effusion was noticed after mapping and at the start of the ablation.The ultrasound and fluoro confirmed the effusion.Pericardiocentesis was performed to drain the fluid from the pericardial space.400 cc of blood were recycled back into the patient at first, nut then the pigtail catheter was connected to a vacutainer.Remainder of the procedure was aborted.The patient as then transferred to the operating room for a thoracotomy.The patient was moved to the intensive care unit and required prolonged hospitalization.Patient had fully recovered from the event.Physician¿s opinion regarding the cause of the adverse event is that it occurred due to catheter manipulation during mapping.Mapping was initially done with a pentaray nav high-density mapping eco catheter and then continued with the thermocool® smart touch® sf bi-directional navigation catheter.Transseptal puncture was performed with a bayless nrg needle.A total of 2 radio frequency applications for 16 seconds were done.Default stsf irrigation settings (2ml/min) were used.The force visualization features used included graph and vector.The parameters of stability used with the visitag module were range 2mm and time 5 seconds.Impedance (0-10ohms) was used as coloring option.No bwi product malfunctions nor error messages were reported.Given the physician believes the issue occurred due to catheter manipulation during mapping, and the mapping was done with two different catheters (pentaray nav high-density mapping eco catheter and thermocool® smart touch® sf bi-directional navigation catheter) the event is being conservatively reported under both.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation on 12/9/2020.The device evaluation was completed on 12/11/2020.It was reported that a 57-year-old male patient with history of prior atrial fibrillation (afib) ablation procedure, left ventricle dysfunction and amiodarone, underwent an afib ablation procedure with a pentaray nav high-density mapping eco catheter.Pericardial effusion was noticed after mapping and at the start of the ablation.The ultrasound and fluoro confirmed the effusion.Pericardiocentesis was performed to drain the fluid from the pericardial space.400 cc of blood were recycled back into the patient at first, but then the pigtail catheter was connected to a vacutainer.Remainder of the procedure was aborted.The patient was then transferred to the operating room for a thoracotomy.The patient was moved to the intensive care unit and required prolonged hospitalization.Patient had fully recovered from the event.The catheter was visually inspected and it was found in good normal conditions.Then, a deflection test was performed and the catheter passed the test, no deflection issues were detected.Also, the catheter was connected to the carto 3 system and it was found working to specification, no errors were observed.After that, a patency flow test was performed and no irrigation issues were detected, the hole was flushing correctly.Finally, an electrical test was performed and it was found in specification, no electrical issues were detected.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.The customer complaint regarding the adverse event cannot be duplicated as intended.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The device is working in specification.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
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10824476
• MDR Text Key: 216614805
• Report Number: 2029046-2020-01674
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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: 08/13/2023
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30428269L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; NON BWI- BAYLESS NRG NEEDLE; THMCL SMTCH SF BID, TC, F-J; UNKNOWN BRAND PIGTAIL CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR