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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053
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BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053 Back to Search Results
Catalog Number D133604IL
Device Problems Image Orientation Incorrect (1305); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2020
Event Type  malfunction  
Manufacturer Narrative
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).
 
Event Description
A patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified a hole on the pebax.It was initially reported by the customer that during the af operation, the force vector displayed on the carto was inverted.A second catheter was used to complete the operation.There was no patient consequence.Despite the incorrect force vector visualization, the device can function as intended, because the catheter can still be displayed using fluoroscopy and carto 3 navigation system.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The risk to the patient is low.As such, this issue is not mdr reportable.On 1/15/2021, the bwi product analysis lab received the complaint device for evaluation.On (b)(6) 2021, a reddish material was found inside the pebax and also a hole in the pebax.This finding was assessed as an mdr reportable malfunction since the integrity of the device was compromised.
 
Manufacturer Narrative
A patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified a hole on the pebax.It was initially reported by the customer that during the af operation, the force vector displayed on the carto was inverted.A second catheter was used to complete the operation.There was no patient consequence.Device evaluation details: the product was returned to biosense webster for evaluation and evaluation has been completed.Visual inspection and microscopic examination of the returned device was conducted.Visual analysis of the returned catheter revealed a reddish material inside the pebax and a hole on the surface of the pebax.Force test could not be performed due to failure in temperature.A failure analysis was performed and it was found that there is a loss of electrical resistance from the cut to the tip creating the temperature issue.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no force issue could be reach on the cause of the reported event.To minimize force issues, the following guidelines should be followed.When applying high lateral force during mapping and rf application, the user should monitor the contact force dashboard and vector display on the carto®3 system screen to ensure that contact force measurements remain within the accurate range.On other hand, regarding the additional finding observed, the instruction for use contains the following information: 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.The customer complaint regarding force issue was unable to duplicate during the product investigation however, the blood inside the pebax area found could be related to the reported issue.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 ELECTROPHYSIOLOGY CATHETER
Type of Device
SIMILAR DEVICE D133601, PMA # P030031/S053
Manufacturer (Section D)
BIOSENSE WEBSTER INC
33 technology drive
irvine CA 92618
MDR Report Key11441298
MDR Text Key268139535
Report Number2029046-2021-00321
Device Sequence Number1
Product Code LPB
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
Report Date 12/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/03/2021
Device Catalogue NumberD133604IL
Device Lot Number30396920M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Date Manufacturer Received03/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARTO 3 SYSTEM.; THMCL SMARTTOUCH,TC,D,C3,OBL.
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