Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number D134801
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2019
Event Type  malfunction  
Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a foreign material issue was encountered.It was reported that before the procedure was started there was unknown, dust-like substance on the device when it was opened.The device was not used and the catheter was exchanged for another catheter to resolve the issue.The procedure was completed without patient's consequence.The issue of foreign material has been assessed as an mdr reportable malfunction.
 
Manufacturer Narrative
It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a foreign material issue was encountered.It was reported that before the procedure was started there was unknown, dust-like substance on the device when it was opened.The device was not used and the catheter was exchanged for another catheter to resolve the issue.The procedure was completed without patient's consequence.Device evaluation details: the device evaluation has been completed.Upon receiving, the catheter was visually inspected, and it was found an unknown particle was observed inside the closed package.Per the complaint, the catheter was sent to ftir (fourier transform infrared spectroscopy).The ft-ir revealed the particle is mainly composed of polymeric material specifically nylon-base material.Presumably, rocker arm component can be pinpointed as the potential source origin.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.An internal corrective action has been created to investigate this issue related with rocker arm particles.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
On 1/2/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis found the sterile pouch looked untouched and unopened.The unused product was still in its sealed pouch and in the original outer box.The outer cellophane wrapping was opened / ripped at one end of the outer box.The returned condition was assessed to not be mdr reportable, however, the complaint continues to be deemed mdr reportable based on the customer¿s initial complaints.During this initial evaluation, the lot # was also able to be verified as 30255870m.Field # d4.Lot has been populated along with the d4.Expiration date of 7/9/2020 and the h4.Device manufacture date of 7/10/2019.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.Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9527726
MDR Text Key200058411
Report Number2029046-2019-04070
Device Sequence Number1
Product Code LPB
UDI-Device Identifier10846835010145
UDI-Public10846835010145
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,foreig
Type of Report Initial,Followup,Followup
Report Date 12/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/09/2020
Device Model NumberD134801
Device Catalogue NumberD134801
Device Lot Number30255870M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Date Manufacturer Received03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-