MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SF CARTO 3,D-F,TC; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	BNI35DFCT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional 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.The device history record (dhr) for the lot number 17701145l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(6).Concomitant products: 1.Smartablate generator, us catalog #: g4c-0775, serial #: (b)(4).2.Smartablate pump, us catalog #: g4cp-0813, serial #: (b)(4).(b)(4).
Event or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a thermocool sf navigational catheter.It was reported that char was found on the tip of the catheter during a procedure.There were no patient consequences.The catheter was cleaned off and used to finish the case.Additional information was received on the event on (b)(6) 2017.The generator was set to power control at 50w max and 40 degrees cutoff.There were no errors or product problems noted.There were no issues related to temperature or flow on the catheter.It was noted that the temperature was 32 degrees, impedance 115ohms, and 40 watts.They used 1000 heparin.They clarified that the material found attached to the tip of the catheter was not char, but coagulum.The patient did not exhibit any neurological symptoms since the procedure was completed.Originally the char was assessed as not reportable.However, since we received clarification that the material was not char, but coagulum, the coagulum has been assessed as a reportable malfunction.Therefore, the awareness date is reset to (b)(6) 2017.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 12/21/17.It was noted that it was returned in the condition reported.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.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
Investigation summary: it was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a thermocool sf navigational catheter.It was reported that char was found on the tip of the catheter during a procedure.There were no patient consequences.The catheter was cleaned off and used to finish the case.Additional information was received on the event on (b)(6) 2017.The generator was set to power control at 50w max and 40 degrees cutoff.There were no errors or product problems noted.There were no issues related to temperature or flow on the catheter.It was noted that the temperature was 32 degrees, impedance 115ohms, and 40 watts.They used 1000 heparin.They clarified that the material found attached to the tip of the catheter was not char, but coagulum.The patient did not exhibit any neurological symptoms since the procedure was completed.The returned device was visually inspected and during the first visual inspection coagulum was found on the catheter tip.However, the lab then clarified that the material was char.No char was observed during the second visual inspection, this could be related to the decontamination process during the first inspection.Per the event, the catheter was tested for electrical performance and stockert compatibility and it was found within specifications.Then a cool flow pump test was performed and the catheter passed specifications, the catheter was irrigating correctly.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.The customer complaint has been verified.However, the catheter functionality was found within specifications.No issues were observed.Additionally, char is a physical phenomenon of radio frequency.It can be the normal result of the ablation process.(b)(4).

• Brand Name: THERMOCOOL SF CARTO 3,D-F,TC
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 91765
• MDR Report Key: 7062443
• Report Number: 2029046-2017-01184
• Device Sequence Number: 1895267
• Product Code: LPB
• UDI-Device Identifier: 10846835003208
• UDI-Public: (01)10846835003208(11)170712(17)200630(10)17701145L
• Combination Product (Y/N): N
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: BNI35DFCT
• Device Catalogue Number: BNI35DFCT
• Device Lot Number: 17701145L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 11/02/2017; 11/02/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 01/02/2018; 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1