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¿ ELECTROPHYSIOLOGY 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¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Catalog Number D133601
Device Problems Entrapment of Device (1212); Failure to Unfold or Unwrap (1669)
Patient Problem No Code Available (3191)
Event Date 03/22/2019
Event Type  Injury  
Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30029765m number, and no internal action was found during the review.(b)(4).
 
Event Description
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a medical device entrapment occurred requiring surgical intervention.During mapping phase, the physician noticed the thermocool® smart touch¿ electrophysiology catheter was abnormally pulled in the aorta from left ventricle (lv).After few attempts to restore catheter¿s position in the lv, it was noticed on x-ray that the thermocool® smart touch¿ electrophysiology catheter had a knotted in a ¿8¿-like shape (double looped).The physician attempted to undo the knot in the lv or aorta without success, the catheter was pulled out to be inspected.When retracted, it got stuck in the iliac artery without possibility to me moved.Reminder of the procedure was cancelled.After 2 hours, another physician from invasive cardiology department succeeded to advance the catheter to the lv and unknotted it and retracted it.Stents were used.Upon catheter removal, no physical damages, such as internal wires exposed, or detached components were observed.The patient was reported in stable and improved condition.Extended hospitalization was not required as a result of the issue experienced.Physician¿s opinion regarding the cause of the event is that it was procedure and bwi product malfunction related.The sheath used during the case was an input sheath, medtronic, 8 f.The force visualization features used were dashboard and vector.Visitag module was not used.The color option used prospectively was force.The physician considered the flexibility of the thermocool® smart touch¿ electrophysiology catheter was hard when handling.This event has been reviewed with the medical safety officer (mso), with the information available, it is not believed that the stents used were used to dilate the vessel; however, it is possible that after removal of catheter, they may have used a covered stent to prevent any bleeding from the site; therefore ¿surgical intervention¿ is being placed as patient code.
 
Manufacturer Narrative
On 4/30/2019, the bwi product analysis lab received the device for evaluation.Initial visual analysis found that no visual damage or anomalies observed.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.Manufacturer's ref.# (b)(4).
 
Manufacturer Narrative
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a medical device entrapment occurred requiring surgical intervention.During mapping phase, the physician noticed the thermocool® smart touch¿ electrophysiology catheter was abnormally pulled in the aorta from left ventricle (lv).After few attempts to restore catheter¿s position in the lv, it was noticed on x-ray that the thermocool® smart touch¿ electrophysiology catheter had a knotted in a ¿8¿-like shape (double looped).The physician attempted to undo the knot in the lv or aorta without success, the catheter was pulled out to be inspected.When retracted, it got stuck in the iliac artery without possibility to me moved.Reminder of the procedure was cancelled.After 2 hours, another physician from invasive cardiology department succeeded to advance the catheter to the lv and unknotted it and retracted it.Stents were used.Upon catheter removal, no physical damages, such as internal wires exposed, or detached components were observed.The patient was reported in stable and improved condition.Extended hospitalization was not required as a result of the issue experienced.Physician¿s opinion regarding the cause of the event is that it was procedure and bwi product malfunction related.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions, no physical damages were observed.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor was tested and it was working properly, the force values were observed within specifications.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, the irrigation and deflection test were performed and it was found within specifications, the catheter was irrigating and deflecting correctly.It was additionally noticed that the expiration date (03/12/2019) was earlier than the event date ((b)(6) 2019) and this situation was confirmed by the customer.For that reason, the shipping history of the lot 30029765m was reviewed and the lot was released (03/15/2018) and shipped to the distribution center, finally the device was shipped to the account (05/24/2018).There are no issues related to the shipping/distribution of the device within the j&j controls.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The ifu states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Customer provided pictures of the reported issue and it was observed the abnormal condition, however, the product analysis does not show any malfunction that could be related to the event, the root cause could be related to the manipulation of the device during the procedure.Manufacturer¿s ref # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
33 technology drive
irvine CA 92618
MDR Report Key8510120
MDR Text Key141789785
Report Number2029046-2019-02975
Device Sequence Number1
Product Code LPB
UDI-Device Identifier10846835008982
UDI-Public10846835008982
Combination Product (y/n)N
PMA/PMN Number
P030031/S053
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 03/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/12/2019
Device Catalogue NumberD133601
Device Lot Number30029765M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2019
Date Manufacturer Received07/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
-
-