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

Model Number D134801

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/10/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter name and address: initial reporter phone: (b)(6).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).

Event Description

It was reported that a patient underwent an unknown procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and an issue with foreign body occurred.It was reported that the contact force (cf) felt strange.At approximately one hour after the start of ablation, it seemed to have no particular problem with repeating the zeroing several times; however, the physician stated that the patient felt something strange, so the smart touch sf catheter was replaced.The procedure was completed without patient consequence.No further information is available.The force issue is not mdr reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Additional information was received on 22-dec-2022.Clarification was received regarding the previously reported event of: ¿the physician said the patient felt something strange".It was corrected to: ¿the physician said that he/she felt something strange¿.Confirmation was also received that there was no foreign material.Sheath information was not available.The physician felt discomfort during use of the catheter.After reassessment of the event by a clinician, it was determined that no foreign body was reported but interpreted to be a strange feeling due to reported contact force issue.Therefore, the event will no longer be considered mdr reportable under mfr # 2029046-2022-03068.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: 15947908
• MDR Text Key: 305143990
• Report Number: 2029046-2022-03068
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30863140L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2022
• 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
• Treatment: UNK BRAND CATHETER
• Patient Outcome(s): Other