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

Catalog Number D134701SI

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

Patient Problems Death (1802); Heart Failure (2206)

Event Date 11/14/2017

Event Type  Death  

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.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 17667184l number, and no non-conformances were found during the review.Manufacturer¿s ref (b)(4).

Event Description

During a clinical trial sponsored by biosense webster inc.(bwi) it was reported that a (b)(6) female patient underwent a paroxysmal atrial fibrillation ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and developed elevated b- type natriuretic peptide (requiring medication) and congestive heart failure that led to death.On post-procedure day 282, the patient developed elevated b- type natriuretic peptide.An unspecified medication was administered.Issue was reported as ongoing and unchanged.The principal investigator assessed this event as moderate in severity, not serious, possibly investigational device related and possibly index procedure related.On post-procedure day 445, the patient developed congestive heart failure.An unspecified medication was administered.Issue was reported as ongoing and improved.The principal investigator assessed this event as moderate in severity, not serious, possibly investigational device related and possibly index procedure related.On post-procedure day 452, the patient was readmitted to the hospital with congestive heart failure (chf) that led to death.An unspecified medication was administered; however, patient¿s condition did not improve, and the patient expired on (b)(6) 2019.The principal investigator assessed the event as severe in severity, serious, possibly investigational device related and possibly index procedure related.This event was originally considered non-reportable, however, bwi became aware of additional information on (b)(4) 2019 when the principle investigator reassessed the adverse events as possibly investigational device related and possibly index procedure related.In addition, the patient¿s death was reported.Therefore, the awareness date for this record is (b)(4) 2019.

Manufacturer Narrative

On 7/15/2019, information was received from the clinical study team indicating the reportable patient adverse events had been removed from the clinical study database.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On (b)(6) 2019, biosense webster inc.(bwi) received additional information about the reported event.It was reported that the adverse events of congestive heart failure developed by the patient on post procedure days 445 and 452 and followed by the patient¿s death have been reassessed by the principle investigator as not related to study device or study procedure.As such, these events are no longer considered mdr reportable against any bwi products.However, since this event has already been reported to fda, biosense webster inc.Will continue to report supplemental mdrs to fda as additional information is received regarding this event.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On 8/20/2019, biosense webster inc.Received additional information indicating all the clinical adverse events previously reported to be inactivated were not inactivated and remain active.As such, the adverse events of elevated b- type natriuretic peptide (requiring medication) and congestive heart failure that led to death remain active.However, the elevated b- type natriuretic peptide (requiring medication) remains possibly investigational device related and possibly index procedure related.The congestive heart failure that led to death continues to be classified as not related to the investigational device and not related to the procedure; however, since these events have already been reported to the fda, biosense webster inc.Will continue to report supplemental mdrs to fda as additional information is received regarding this event.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 8434864
• MDR Text Key: 139285766
• Report Number: 2029046-2019-02835
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: D134701SI
• Device Lot Number: 17667184L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 78 YR