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

Model Number D132705

Device Problem Break (1069)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

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 an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.The tip was damaged.Catheter tip damage.No adverse events for patient.No further information available.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Broken tip is mdr-reportable.

Manufacturer Narrative

On (b)(6) 2021, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4).

Manufacturer Narrative

On(b)(6)-2021, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.The tip was damaged.Catheter tip damage.No adverse events for patient.No further information available.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a general inspection through the visual inspection.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool smarttouch 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 laboratory analysis.A manufacturing record evaluation was performed for the finished device 30533725m number, and no internal action related to the complaint was found during the review.The instructions for use contain the following warning stated in the instructions for use (ifu): do not scrub or twist the distal tip electrode during cleaning.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 BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12191581
• MDR Text Key: 263602823
• Report Number: 2029046-2021-01147
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2022
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30533725M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1