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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER
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BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Catalog Number D134805
Device Problems Image Orientation Incorrect (1305); Contamination /Decontamination Problem (2895); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
Event Type  malfunction  
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the clear space area had blood inside that could be squeezed out.The area on the ablation catheter between the proximal and distal electrode, near the m3 electrode seal there appears to be a leak.The caller stated that it was causing the force vector to jump all over the place and the temperature reading was going in and out.The catheter was replaced and the issue resolved.There was no patient consequence.
 
Manufacturer Narrative
The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
 
Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the clear space area had blood inside that could be squeezed out.The area on the ablation catheter between the proximal and distal electrode, near the m3 electrode seal there appears to be a leak.The caller stated that it was causing the force vector to jump all over the place and the temperature reading was going in and out.The catheter was replaced and the issue resolved.There was no patient consequence.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and microscopy examination, screening, temperature and impedance of the returned device was performed following bwi procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.The force feature was tested and no errors were observed.The force values and the vector were observed within specifications.No vector inverted or other force issues were observed.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal action were identified.The reddish material inside the pebax could be related to the force and temperature issue reported by the customer; therefore, the customer complaint were confirmed.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The instruction for use states: when cleaning the tip electrode, be careful not to twist the tip electrode with respect to the catheter shaft; twisting may damage the tip electrode bond and loosen the tip electrode, or may damage the contact force sensor.In addition, in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.After insertion, slide the insertion tube back toward the handle.In relation to the force and temperature issue, the instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.If the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
 
Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 25-mar-2024, it was discovered the h6.Medical device problem codes of "image orientation incorrect (a090205)" and "device sensing problem (a0709)" were inadvertently omitted from the 3500a initial medwatch report.Codes have now been added.
 
Manufacturer Narrative
On 1-mar-2024, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).
 
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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 Key18764771
MDR Text Key336967763
Report Number2029046-2024-00602
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberD134805
Device Lot Number31170721L
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received04/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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