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

Model Number D134805

Device Problems Break (1069); Positioning Problem (3009)

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

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a broken tip issue occurred.It was reported that the tip of the catheter broke intra-op.It is normal that the catheter has bi-directional curves (d/f), but one of the curves was broken and did not spread out during the procedure.The physician could not manipulate the catheter properly.The physician requested to change the catheter and so it was replaced with a new one, and it has curved well without any curve problem.The procedure was completed without patient consequence.Additional information was received and it was reported that the damage did not result in wires and/or braid being exposed.The damage did not result in any lifted or sharp rings.It was quite tough to insert catheter into sheath.The detachment was partial.The device was detached at the tip ¿ shaft transition.

Manufacturer Narrative

On 18-nov-2021, the biosense webster, inc.Product analysis lab received the device for evaluation.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.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 device evaluation was completed on 14-dec-2021.It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a broken tip issue occurred.It was reported that the tip of the catheter broke intra-op.It is normal that the catheter has bi-directional curves (d/f), but one of the curves was broken and did not spread out during the procedure.The physician could not manipulate the catheter properly.The physician requested to change the catheter and so it was replaced with a new one, and it has curved well without any curve problem.The procedure was completed without patient consequence.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and failure analysis of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.A manufacturing record evaluation was performed for the finished device 30604436l number, and no internal action related to the complaint was found during the review.A deflection test was performed and it was found within specifications as the catheter was deflecting correctly.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No deflection or other issues were verified during the analysis.The instructions for use contain the following recommendations: inspect all components before use.The event described could not be confirmed as the device performed without any deflection issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12808772
• MDR Text Key: 282736964
• Report Number: 2029046-2021-01974
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30604436L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• 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 ABBOTT AGILIS 8.5 FR; UNK BRAND CATHETER