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

Catalog Number D133604IL

Device Problems Partial Blockage (1065); Material Puncture/Hole (1504)

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

Event Date 03/09/2022

Event Type  malfunction  

Event Description

A patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified a hole on the pebax.The finding was identified on (b)(6) 2022.It was initially reported by the customer that during the operation, there was an intermittent or low irrigation on the device but not complete occlusion.A second catheter was used to complete the operation.There was no adverse event reported on patient.Inadequate irrigation is not mdr-reportable.Hole in the pebax is mdr-reportable.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed a hole was found in the pebax, and the tip was found bent; no other damage or anomalies were observed on the smart touch unidirectional catheter.An irrigation test was performed, per bwi procedures.The catheter was irrigating correctly, no water leakage was observed during the investigation.The instructions for use contain the following recommendations: before use, check irrigation ports are patent by infusing heparinized normal saline through the catheter and tubing.Also, do not continue to use the catheter if still occluded or if it is not functioning properly.The event described could not be confirmed as the device performed without any irrigation issues.Although no irrigation 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.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal actions related to the complaint were found during the review.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¿ ELECTROPHYSIOLOGY 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15333489
• MDR Text Key: 302953829
• Report Number: 2029046-2022-02072
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Catalogue Number: D133604IL
• Device Lot Number: 30679527M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2022
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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