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

Model Number D134805

Device Problems Partial Blockage (1065); Separation Problem (4043)

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

Event Date 03/16/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.There was a gap behind the tip and above the force sensor chamber that was altering irrigation.Before the ablation catheter was put into the body, the physician was flushing it and they noticed that the water was leaving the catheter in a large stream, rather than the usual "fan shaped-spray.Upon inspection there seemed to be a gap behind the tip and above the force sensor chamber.The catheter was replaced, and the procedure continued.No patient consequences were reported.The damage did not result in wires and/or braid being exposed or any lifted or sharp rings.The catheter was never inserted.The sheath was a st.Jude swartz 8.0 fr, however, the catheter was never inserted into sheath.The catheter package was not damaged.There was no error message.The issue was noticed while pre-flushing stsf catheter prior to insertion into body.The physician and the bwi company representative noticed there was a large amount of water jetting from the front tip and not in the usual fan shape more of a water stream.Physician never inserted catheter into sheath or body and asked for new catheter immediately.The issue was resolved by changing to a new catheter.A nav tcool smarttouch sf catheter was used.Clarification provided by bwi company representative regarding report that there ¿seemed to be a gap at the tip¿.They state that after the physician noticed that the spray was wrong that he took a closer look at the porous tip where it meets the catheter shaft and he stated that it looked like there was a gap that shouldn¿t be there and when flushing it looked like it was coming out of the gap which was possibly causing the weird looking flush versus the normal fan shaped flush.Inadequate irrigation is not mdr-reportable.Partial tip separation is mdr-reportable.

Manufacturer Narrative

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.Manufacturer's reference number:(b)(4).

Manufacturer Narrative

On 2-may-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.There was a gap behind the tip and above the force sensor chamber that was altering irrigation.Device evaluation details: visual analysis revealed no damage or anomalies on the device.A cool flow pump and pressure gage test was performed, and the device was irrigating correctly.No irrigation issues were observed.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations: flush the catheter with heparinized saline prior to insertion into the body.A manufacturing record evaluation was performed for the finished device [30701821l] number, and no internal actions related to the reported complaint condition were identified.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14075282
• MDR Text Key: 289020996
• Report Number: 2029046-2022-00775
• 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
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30701821L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• 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: ST. JUDE SWARTZ 8.0 FR