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

Model Number D134805

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone #: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device with lot number 30262369m, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac tamponade which required pericardiocentesis.During the procedure, an airway maintenance device was used to manage breathing, but because of repeated sudden breathing due to sleep apnea syndrome, sedation was stopped and switched to spontaneous breathing.However, the catheter placement was unstable due to repeated deep breathing in the awake state.There was no sudden drop in blood pressure, however a cardiac tamponade was confirmed.After the procedure, pericardiocentesis was performed and about 300 to 400 ml of venous blood was removed.The patient was conscious and conversing when leaving.The surgeon confirmed a sense of incongruity during the procedure and commented that there was no mechanical problem and does not associate the event to the carto 3 system.There is no further information about the hospitalization.The patient's breathing was unstable with sudden inhalation deeply after apnea.Physician believes this was because the control was not effective because the patient took a deep breath even after the patient got up.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Additional information was received on (b)(6)2019 on the event.The patient was male.In the opinion of the physician, the cause of the event was the patient¿s condition.The patient¿s condition was improved.Therefore, populated a3.Sex.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: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9507842
• MDR Text Key: 188850894
• Report Number: 2029046-2019-04052
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Report Date: 11/26/2019

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: 07/23/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30262369M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM WITH CARTO MERGE
• Patient Outcome(s): Life Threatening; Required Intervention