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

Model Number D134805

Device Problems Pacing Problem (1439); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that during a cardiac ablation procedure, after connected the thermocool® smart touch® sf bi-directional navigation catheter, error 503 appeared.Adjustment was done, and the left pulmonary vein (lpv) ablation started.After 2 ablations, error 8 was displayed.The pacing leads were connected to the primary pacing port.The carto did not allow to pace and ablate at the same time; however, unwanted pacing was delivered.The catheter was replaced, and the procedure was continued and subsequently completed.No patient consequences were reported.Error 503 is related to noise on the location pad; however, since the error was displayed after catheter connection and did not require any system reboot nor location pad replacement.It was confirmed no noise issues with the catheter were experienced.The carto recognition issues are not mdr-reportable.The unwanted pacing is mdr-reportable.

Manufacturer Narrative

On (b)(6) 2021, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that during a cardiac ablation procedure, after connected the thermocool® smart touch® sf bi-directional navigation catheter, error 503 appeared.Adjustment was done, and the left pulmonary vein (lpv) ablation started.After 2 ablations, error 8 was displayed.The pacing leads were connected to the primary pacing port.The carto did not allow to pace and ablate at the same time; however, unwanted pacing was delivered.The catheter was replaced, and the procedure was continued and subsequently completed.No patient consequences were reported.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, carto 3 and electrical evaluation of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the smart touch bidirectional sf.Carto 3 and electrical testing was performed, in accordance with bwi procedures.The catheter was working correctly, and no recognition or electrical issues were detected during the analysis.A manufacturing record evaluation was performed for the finished device 30448282m lot number, and no internal action related to the complaint was found during the review.No recognition or electrical issues could be reach on the cause of the reported event.The instructions for use contain the following recommendations for recognition issue: allow six seconds after a catheter is connected for the system to recognize it.Allow up to six seconds after a catheter is disconnected before connecting another catheter to the same socket.The event described could not be confirmed as the as the device performed without any issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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: 11408841
• MDR Text Key: 266243919
• Report Number: 2029046-2021-00273
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30448282M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM