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

Catalog Number D134722IL

Device Problem Signal Artifact/Noise (1036)

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

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and electrical evaluation of the returned device.Visual analysis of the returned sample revealed that the catheter was inspected and it was found that an electrode was damaged.Sharp edges were observed due to lifted electrode was observed on the stsf.This issue could have happened due to excessive force or manipulation, however, this cannot be conclusively determined.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.A manufacturing record evaluation was performed for the finished device 30483439l number, and no internal action was found during the review.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no electrical issue could be reach on the cause of the reported event.To minimize ecg noise, the following guidelines should be followed.Ecg noise is typically generated as the result of improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify proper connection.It is recommended to turn off the notch filter for this verification.The event described could not be confirmed as the as the device performed without any electrical 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 laboratory 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).

Event Description

A patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® catheter for which biosense webster¿s product analysis lab identified a damaged/lifted electrode resulting in exposed sharp edges.During the procedure, signal interference noise was observed on ic, bs, and ecg channels.A second catheter was used to complete the operation.No patient consequences were reported.The noise issue is not mdr-reportable.The damaged electrode and sharp edges are mdr-reportable.

• Brand Name: THERMOCOOL SMART TOUCH CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12037129
• MDR Text Key: 263531624
• Report Number: 2029046-2021-00959
• Device Sequence Number: 1
• Product Code: LYB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2021
• Device Catalogue Number: D134722IL
• Device Lot Number: 30483439L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1