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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bradycardia (1751); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30356864m 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 ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac failure.During the procedure, pulmonary vein dilation was performed as usual, and after confirming the sinus node position, superior vena cava (svc) was isolated.Finally, over rive suppression test was performed, and no abnormalities were observed.The procedure was successfully completed.No bwi product malfunctions were reported.On post-procedure day 1, the patient suddenly developed bradycardia that led to heart failure.There¿s no information regarding interventions or prolonged hospitalization.Patient¿s outcome is unknown.Physician commented that since no device deficiencies occurred, it seems there¿s no causal relationship between the bwi product and the adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available, this is being conservatively coded and reported as ¿cardiac failure¿ as the condition occurred within 365 days post-procedure.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

On (b)(6) 2021, additional information was received indicating the patient suffered cardiac failure requiring surgical intervention (device insertion) and prolonged hospitalization.An unspecified device was inserted for intervention.Patient was male.With the information available, this event was conservatively reported as ¿cardiac failure¿ as the condition occurred within 365 days post-procedure.Should more information become available, it will be reviewed and processed accordingly.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 4/19/2021, during an internal review it was determined that this event should have also been coded with the h6.Health effect code of "bradycardia (e060104)", therefore, the code has now been added to the appropriate field since it was not reported in any of the previously submitted medwatch reports.

• 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: 11282889
• MDR Text Key: 230469173
• Report Number: 2029046-2021-00137
• 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,Followup
• Report Date: 01/11/2021

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: 02/27/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30356864M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 02/08/2021; 04/19/2021
• Supplement Dates FDA Received: 03/05/2021; 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening