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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 Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2018
Event Type  malfunction  
Manufacturer Narrative
The bwi product analysis lab (pal) 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.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacture reference no: (b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure for atrioventricular nodal re entrant tachycardia (avnrt) with a thermocool® smart touch® sf bi-directional navigation catheter and a inadequate irrigation issue occurred on the tip of the catheter.Catheter replacement resolved the issue.No adverse patient consequences were reported.The inadequate irrigation issue has been assessed as not reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event is being reported because on (b)(6) 2018, the bwi product analysis lab (pal) received the device for evaluation and found occluded tip dome holes, off white and brownish foreign material, and a broken rocker arm off the handle.The issue of the occluded tip dome hole and broken rocker arm has been assessed as not reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The observed off white and brownish foreign material has been assessed as mdr reportable.The awareness date has been reset to 12/10/2018.
 
Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for atrioventricular nodal re entrant tachycardia (avnrt) with a thermocool® smart touch® sf bi-directional navigation catheter and a inadequate irrigation issue occurred on the tip of the catheter.The investigational analysis completed on 4/22/2019.The device was inspected and the tip dome was observed occluded with white and brownish material.Additionally, rocker arm was found separate from the handle.An irrigation test was performed and the catheter failed.Fourier transform infrared spectroscopy testing (ftir) was performed and the results showed that the foreign material is composed of silicon -based material, presumably dimethyl siloxane better known as silicone.This material is widely used in lubricant, cosmetics, and the medical industry among others.However, the source of origin remains unknown.The manufacture team performed an investigation in order to determine the root cause.The investigation results showed that this issue is not related to the process.The entire process was reviewed, and no source of origin was found.The manufacture process is free of silicone usage.This issue is not related to manufacturing.However, an awareness session was provided for involved personnel.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint was confirmed.The root cause of the occlusion and the rocker arm separate from the handle cannot be related to the manufacture process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the procedure.Manufacture reference no: (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
33 technology drive
irvine CA 92618
MDR Report Key8227510
MDR Text Key132593787
Report Number2029046-2019-02540
Device Sequence Number1
Product Code LPB
UDI-Device Identifier10846835010183
UDI-Public10846835010183
Combination Product (y/n)N
PMA/PMN Number
P030031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/16/2018
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 Date04/11/2019
Device Catalogue NumberD134805
Device Lot Number30042756L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Initial Date Manufacturer Received 12/10/2018
Initial Date FDA Received01/08/2019
Supplement Dates Manufacturer Received04/22/2019
Supplement Dates FDA Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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