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

Model Number D134805

Device Problems Material Separation (1562); Mechanical Jam (2983)

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

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental 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 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 a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a ¿catheter shaft broke inside the patient¿ issue occurred.During the procedure, (catheter inside the patient), when handling the catheter or it has been damaged.It did not cause any risk to the patient, it was removed and discarded by the nursing team as part of the hospital protocol.It was not known if the surgery was delayed or if the procedure was completed.It was not known if they removed it easily without additional intervention.There was no patient consequence reported.Additional information was received.The catheter curve broke during handling.No error message was displayed, the physician noted during handling.The catheter bend broke during handling.Procedure completed successfully.The issue was resolved by catheter replacement.No harm was done to the patient.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available, this event was assessed as mdr reportable for ¿catheter shaft broken inside the patient¿.

Manufacturer Narrative

The investigation was completed on 15-mar-2023.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 22-mar-2023.The catheter was bidirectional, when performing the maneuver to change the curve, it was fractured.It was a deflection issue.It was a problem deflecting from one turn to another.It stayed in the deflected position.There was no physical damage.Just unable to make the other turn.There were no withdrawal difficulties.The catheter was collected by the hospital according to the establishment¿s protocol.The preface 8f sheath was used.Therefore, the event was reassessed from a reportable "catheter shaft broke inside the patient¿ issue to a "deflection stuck" issue.Hence, updated h6.Medical device problem code from ¿material separation (a0413)¿ to ¿mechanical jam (a0506)¿.In addition, updated the d10.Concomitant medical products and therapy dates field to include the preface 8f sheath.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: 16538069
• MDR Text Key: 311592234
• Report Number: 2029046-2023-00523
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2023

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 Expiration Date: 07/08/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30850938L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 03/15/2023; 03/22/2023
• Supplement Dates FDA Received: 03/16/2023; 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2022
• 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: PREFACE 8F SHEATH; UNKNOWN BRAND CATHETER