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

Model Number D134805

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 08/04/2022

Event Type  malfunction  

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 an open pouch seal issue occurred.There was hard plastic poking outside of the sterile plastic of the packaging for the catheter.They did not use the catheter.They replaced the catheter and the procedure continued.There was no foreign material.The inner hard plastic packaging was protruding from the outer sterile packaging.The staff notified me when i arrived.Packaging was discarded at that time.No adverse patient consequence was reported.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 31-aug-2022.The device evaluation was completed on 21-sep-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and an open pouch seal issue occurred.There was hard plastic poking outside of the sterile plastic of the packaging for the catheter.They did not use the catheter.They replaced the catheter and the procedure continued.There was no foreign material.The inner hard plastic packaging was protruding from the outer sterile packaging.The staff notified me when i arrived.Packaging was discarded at that time.No adverse patient consequence was reported.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection of the returned device according to bwi procedures.Visual analysis of the returned sample revealed no anomalies in the device; however the hard plastic, and packaging material reported were not returned; therefore, the analysis could not be performed.A manufacturing record evaluation was performed for the finished device 30814700l number, and no internal actions related to the complaint were found during the review.The issue reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.H 6.Investigation conclusions code of ¿appropriate term/code not available (d17)¿ was selected to represent that the device or packaging cannot be analyzed due to the product returned condition.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; 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: 15327876
• MDR Text Key: 305418957
• Report Number: 2029046-2022-02053
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30814700L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2022
• 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
• Treatment: UNK BRAND CATHETER