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

Model Number D132705

Device Problems Mechanical Problem (1384); Electrical Shorting (2926)

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

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi then conducted visual inspection of the returned device.Visual analysis of the returned sample revealed that tip was cut.The root cause cannot be determined, it could be related to the handling of the device, however, this cannot be conclusively determined.Unit was inspected prior leaving the facility as there are functional tests and inspections at control points based on the process to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal actions related to the reported complaint condition were identified.Although no electrical issue could be reach on the cause of the reported event; to minimize ecg noise, this guidelines should be followed: ecg noise is typically generated as the result of improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify proper connection.It is recommended to turn off the notch filter for this verification.It is recommended that the observation room and the operating room both be connected to a common protective ground.Doing so prevents leakage current between various ep lab equipment and noise on ecg channels.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified that the tip was cut with internal parts exposed.It was initially reported by the customer that there was a current leakage.The adapter was not applicable.The catheter was replaced but a complete loss of bs and ic signals occurred.The catheter was replaced once more and the procedure was successfully completed.No patient consequences were reported.The first catheter (with the current leakage issue) is the complaint device with the cut tip.The current leakage issue is not mdr-reportable.The cut tip with exposed internal parts is mdr-reportable.

• Brand Name: THERMOCOOL SMART TOUCH 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12381536
• MDR Text Key: 268674912
• Report Number: 2029046-2021-01425
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30472021M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• 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
• Patient Age: 73 YR