MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SF BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	BDI35DFRT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Death (1802)
Date of Event	02/28/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturing ref #(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial flutter with a thermocool® sf bi-directional catheter and suffered a cerebrovascular accident (requiring anesthetization) and death.During the procedure, after the administration of rytmonorm (rhythmol, propafenone), the patient entered into a psychotic state.An unspecified sedative was administered.Patient was transferred to the intensive care unit (icu).Patient required extended hospitalization (4 days) as a result of the adverse event.While in the icu, a cerebral hemorrhage was detected.Patient was anesthetized.Patient did not regain consciousness and expired.It was later confirmed that the cerebral hemorrhage occurred during the atrial flutter procedure.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure and patient condition.It was noted that the adverse event (cerebrovascular accident) was attributed to medications used during the procedure.Physician¿s opinion regarding the cause of death was that it was secondary to the cerebral hemorrhage.Since the adverse event resulted in the patient¿s death, it is mdr reportable.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 04/17/2018.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.(b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for atrial flutter with a thermocool® sf bi-directional catheter and suffered a cerebrovascular accident (requiring anesthetization) and death.During the procedure, after the administration of rytmonorm (rhythmol, propafenone), the patient entered into a psychotic state.An unspecified sedative was administered.Patient was transferred to the intensive care unit (icu).Patient required extended hospitalization (4 days) as a result of the adverse event.While in the icu, a cerebral hemorrhage was detected.Patient was anesthetized.Patient did not regain consciousness and expired.It was later confirmed that the cerebral hemorrhage occurred during the atrial flutter procedure.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure and patient condition.Product investigation: the device was visually inspected and it was found in good conditions.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, the irrigation and deflection test were performed and it was found within specifications, the catheter was irrigating and deflecting correctly.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter passed all specifications.The root cause of the adverse event remains unknown.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure and patient condition.The ifu states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.(b)(4).
Additional Manufacturer Narrative
On 6/20/2018, additional information was received indicating the atrial flutter was the right atrium.The patient underwent an ablation procedure for right atrial flutter.(b)(4).

• Brand Name: THERMOCOOL® SF BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7386411
• Report Number: 2029046-2018-01391
• Device Sequence Number: 11036596
• Product Code: LPB
• UDI-Device Identifier: 10846835002812
• UDI-Public: 10846835002812
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/01/2018

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: 10/11/2020
• Device Catalogue Number: BDI35DFRT
• Device Lot Number: 17741108L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 04/17/2018; 04/27/2018; 06/20/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 04/23/2018; 05/24/2018; 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Other; Required Intervention