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

Catalog Number D134804

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

Biosense webster inc.¿s (bwi) product analysis lab (pal) received a thermocool® smart touch® sf bi-directional navigation catheter for which the pal identified ¿the pebax was broken leaving internal parts exposed.¿ the thermocool® smart touch® sf bi-directional navigation catheter was received labeled with a complaint number for which product details, such as product code or lot number do not match.On 17-oct-2023, the device was inspected and it was found that the pebax was found broken leaving internal parts exposed which is considered to be an mdr reportable malfunction.Multiple attempts have been made to obtain clarification for the wrong product received, however, no further information has been made available.A new complaint was created to investigate and report the identified malfunction although no specific event details are available.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster (bwi) for evaluation and the evaluation has been completed.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed the tip was observed dented.The pebax was found broken leaving internal parts exposed.Electrodes 3 and 4 were observed dent, without sharp edges.The magnetic and force feature were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.A manufacturing record evaluation was performed for the finished device lot number, and no internal actions related to the reported complaint condition were identified.It should be noted that product failure is multifactorial.As part of the 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 ref.(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: 18132918
• MDR Text Key: 329095002
• Report Number: 2029046-2023-02629
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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: 31013039L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2023
• 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