MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ THERMOCOOL® BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number BDI75TCDFRT

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

Patient Problems Thrombosis (2100); Cardiac Tamponade (2226)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).

Event Description

It was reported that an (b)(6) male patient underwent an atrial flutter right (r-afl) ablation procedure with an ez steer¿ thermocool® bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis and a thrombosis.During the ablation phase, while ablating the cavotricuspid isthmus (cti), a steam pop occurred.The patient¿s blood pressure dropped, and cardiac tamponade was confirmed.Pericardiocentesis was performed and 1 liter of flood was drained from the pericardium.The patient received anticoagulant (protamine) and he had a thrombus.The activated clotting time (act) is unknown.There¿s no information regarding medical/surgical intervention when the thrombus was noted.It is unknown if extended hospitalization was required as a result of the adverse event.The patient was reported to be in stable condition.Physician¿s causality opinion is unknown.It is unknown if a transseptal puncture was performed.An unknown 8fr 10 cm (lot:we04) introducer and an unknown 6fr, 10cm (lot: 171010a) introducer were used during the procedure.The generator parameters at the site of injury are unknown.There¿s no information regarding overall ablation and last ablation cycle at the site of injury.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since the cardiac tamponade required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it was to be considered serious and mdr reportable.The thrombosis was also assessed as an mdr reportable patient event.The steam pop was not considered to be a device malfunction as it was an expected physiological phenomenon.

Manufacturer Narrative

The device history record was provided on september 10, 2018.The device history record (dhr) for the lot number 30027460m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Correction to follow-up #1.Additional concomitant product was a coolflow tubing/us catalog #/lot #.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Correction to the initial report as "concomitant med products" was processed; however, the concomitant products were not listed.Therefore, below is the listed concomitant products.Concomitant products: non-biosense webster, inc.- abbott inquiry 6fr, 10 electrodes catheter (lot # 6438156).Non-biosense webster, inc.- unknown 8fr 10 cm introducer (lot: we04).Non-biosense webster, inc.- unknown 6fr, 10cm introducer (lot: 171010a).Stockert ep shuttle generator.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on the event on august 13, 2018.Activated clotting time (act) of 156 seconds.Extended hospitalization was required as a result of the adverse event.There were no factors cited that might have contributed to the adverse event.There were no error messages observed on any biosense webster, inc.Equipment during the procedure.Transseptal puncture was not performed.No sheath was used.The catheter flow irrigation was set at 17ml/min.Therefore, outcomes attributed to adverse event is hospitalization initial/prolonged has been populated.In addition, originally the lot number was reported as unknown.However, the lot number has now been provided.Device manufacture date have been populated.Still pending is the device history record.Therefore, a supplemental report will be submitted.Manufacturer's ref.No: (b)(4).

• Brand Name: EZ STEER¿ THERMOCOOL® BI-DIRECTIONAL CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7760748
• MDR Text Key: 116362071
• Report Number: 2029046-2018-01921
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835002874
• UDI-Public: 10846835002874
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2021
• Device Catalogue Number: BDI75TCDFRT
• Device Lot Number: 30027460M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention