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

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).(b)(4).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 30364632m number, and no internal action related to the complaint was found during the review.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 (afib) ablation procedure on (b)(6) 2020 with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.Just before the end of the procedure, after complex fractionated atrial electrograms (cfae) and mitral isthmus line ablation was conducted, there was a drop in the patient¿s blood pressure when the block was completed.The physician checked for an effusion by ultrasound and confirmed pericardial effusion.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.Patient¿s condition recovered after pericardial drainage.The patient was transferred to the intensive care unit (icu).The physician commented that there was no causal relationship between the product and the adverse event and commented that when ablating within the coronary sinus (cs), there was a high possibility that it leaked from where the cs wall was thin.The patient was moved from the icu to general ward and was discharged on (b)(6) 2020.No biosense webster product malfunctions were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this event is life threatening and required medical intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On (b)(6) 2020, bwi received additional information indicating that the patient was 78 years old and weighed 56 kg.After the procedure, it was indicated that the patient's condition improved.Prior to the pericardial effusion, ablation had been performed.There was no report of steam pop.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: 10583748
• MDR Text Key: 208572876
• Report Number: 2029046-2020-01326
• 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: 08/27/2020

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: 03/17/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30364632M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 56