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

Catalog Number D134804

Device Problems Material Puncture/Hole (1504); Insufficient Information (3190)

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

Event Date 04/12/2023

Event Type  malfunction  

Event Description

One thermocool® smart touch® sf bi-directional navigation catheter was received by the bwi product analysis lab with no accompanying information, and was processed on 21-sep-2023.The device could not be associated with an existing complaint.In the absence of clarifying information, it cannot be determined why this device was returned to bwi.However, visual analysis revealed that a hole in the pebax exposing internal components.As a result, this will be reported to fda.

Manufacturer Narrative

Note: the device was received by bwi with no accompanying information, including date of event leading to the complaint device's damage.As a result, the b3 "date of event" has been filled out to its manufacture date of 12-apr-2023.The event could not have occurred prior to manufacture date.The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material inside the pebax.No other anomalies were observed.A screening test was performed and the device was recognized correctly; however, error 106 appeared due to an open circuit in the tip area.Additionally, a microscopic analysis revealed a hole in the pebax exposing internal components.The root cause of the damage could be related to improper handling, however, this cannot be conclusively determined there are control inspection points to avoid these issues.Based on the information currently available, a product issue was identified during the investigation of the sample received.It should be noted that product failure is multifactorial.A manufacturing record evaluation was performed for the finished device number 31038624l, and no internal action was found during the review.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17951051
• MDR Text Key: 326405087
• Report Number: 2029046-2023-02344
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2023

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 Catalogue Number: D134804
• Device Lot Number: 31038624L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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