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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 Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
The biosense webster inc.Product analysis lab 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found the catheter pebax ripped.Initially it was reported that during the procedure a temperature sensor error was displayed.A second catheter was used to complete the operation.No adverse patient consequences were reported.The observed unknown temperature sensor error has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 3/3/2020, the bwi pal received the device for evaluation.Upon initial inspection, the bwi pal observed the pebax of the catheter is ripped.The observed ripped catheter pebax has been assessed as an mdr reportable malfunction, as device integrity was compromised.The awareness date has been reset to 3/3/2020.
 
Manufacturer Narrative
During an internal review on 5/5/2020, it was noticed that the manufacture date and expiration date were omitted in error.Section d4 expiration date has been updated with 5/20/2020 and section h4 manufacture date has been updated with 5/21/2019.Manufacture reference no: (b)(4).
 
Manufacturer Narrative
It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found the catheter pebax ripped.Initially it was reported that during the procedure a temperature sensor error was displayed.The investigational analysis completed (b)(6) 2020.The device was visually inspected and the pebax was found ripped.Electrical testing 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.A cool flow pump test was performed and it was found within specifications.The catheter was irrigating correctly.No irrigation issues were observed.A manufacturing record evaluation was performed and no internal actions were found during the review.The customer complaint cannot be confirmed.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure.However, this cannot be conclusively determined.Manufacture reference no: (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 Key9896074
MDR Text Key200872048
Report Number2029046-2020-00496
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
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 02/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/20/2020
Device Catalogue NumberD133604IL
Device Lot Number30226292M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2020
Date Manufacturer Received05/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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