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

Model Number D133601

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

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and an open pouch seal issue occurred.Sterile plastic catheter packaging was open inside of paper packaging.Staff was not opening it.It was delivered opened.It was unknown if the event occurred during sterile processing or during field inspection.No patient consequences.Additional information was received.Pictures of the open pouch seal not available.Packaging not available anymore.The device was not used on the patient.The event was assessed as mdr reportable for an open pouch seal issue.

Manufacturer Narrative

As stated in the complaint form, the event date is unknown.As a result, the 1st day of the year has been entered as the event date.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and an open pouch seal issue occurred.The investigation was completed on 13-feb-2023.The device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.However, the customer complaint is about the packaging and the original packaging was not returned with the device.A manufacturing record evaluation was performed for the finished device and no internal action related to the complaint was found during the review.The issue reported by the customer could not be confirmed during the product investigation.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.H6.Investigation conclusions of appropriate term/code not available (d17) and h6.Component code of appropriate term/code not available (g07002) represents ¿unable to analyze due to 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).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 04-jan-2023.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).

• 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15978225
• MDR Text Key: 308559877
• Report Number: 2029046-2022-03105
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Device Lot Number: 30881974M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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