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

Model Number D134805

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that an unknown patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.There was foreign material on the tip.The tip of the catheter had foreign material on it after it was taken out of the patient.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.An attempt has been made to obtain clarification to this complaint.However, no further information has been made available.Sheath information: carto vizigo small curve.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The foreign material on the catheter was not char.Foreign material on usable length of catheter is mdr-reportable.

Manufacturer Narrative

On 5-jan-2022, the bwi 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 21-jan-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.There was foreign material on the tip.The tip of the catheter had foreign material on it after it was taken out of the patient.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the smart touch bidirectional sf.The foreign material in the tip could be related to human tissue since the customer reports that it was identified after being taken out of the patient.A manufacturing record evaluation was performed for the finished device [30648702l] number, and no internal actions related to the reported complaint condition were identified.The instructions for use contain the following warning stated: inspect the catheter packaging prior to use.If the package is open or damaged, return the catheter to biosense webster.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: 13016527
• MDR Text Key: 289324368
• Report Number: 2029046-2021-02181
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2022

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: 09/30/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 01/05/2022; 01/21/2022
• Supplement Dates FDA Received: 01/13/2022; 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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: CARTO VIZIGO SHEATH - SMALL CURVE