MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D132704
Medical Device Problem Codes	Insufficient Cooling (1130); Device Contamination with Body Fluid (2317); High Readings (2459); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi 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 information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
A patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheters for which biosense webster¿s product analysis lab identified foreign material at the tip of the returned catheter.During the procedure, the carto 3 system and the smartablate generator were displaying inaccurate impedance and temperature spikes when delivering rf therapy with thermocool® smart touch¿ bi-directional navigation catheter.When the physician removed the thermocool® smart touch¿ bi-directional navigation catheters from the patient's body, they noted the presence of char at the tip of the catheter.It was confirmed that the irrigation functioned properly.The thermocool® smart touch¿ bi-directional navigation catheter was replaced with a like device and the procedure was completed.There was no report of patient consequence.The customer¿s reported issues of high temperature, high impedance and char on thermocool® smart touch¿ bi-directional navigation catheters are not considered to be mdr reportable since the user-defined cut-offs were not exceeded and the potential these could cause or contribute to a death, serious injury, or other significant adverse event, is remote.The presence of char on the electrodes does not represent an mdr-reportable event as well.On (b)(6) 2020, the thermocool® smart touch¿ bi-directional navigation catheter was returned with foreign matter at the tip of the catheter.This finding has been assessed as an mdr reportable malfunction.
Additional Manufacturer Narrative
On (b)(6) 2020, the product investigation was completed.A patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ bi-directional navigation cathetersfor which biosense webster¿s product analysis lab identified foreign material at the tip of the returned catheter.During the procedure, the carto 3 system and the smartablate generator were displaying inaccurate impedance and temperature spikes when delivering rf therapy with thermocool® smart touch¿ bi-directional navigation catheter.When the physician removed the thermocool® smart touch¿ bi-directional navigation catheters from the patient's body, they noted the presence of char at the tip of the catheter.It was confirmed that the irrigation functioned properly.The thermocool® smart touch¿ bi-directional navigation catheter was replaced with a like device and the procedure was completed.There was no report of patient consequence.Device evaluation details: the returned device was visually inspected, and no anomalies were found, the char was not observed in the tip during product analysis, however, a picture was provided by the decontamination lab and char was observed on the catheter tip.Then, the catheter was connected to the generator and no temperature was observed.Also, the catheter was irrigating correctly.A manufacturing record evaluation was performed for the finished device 30369225m number, and no internal action was found during the review.The customer complaint has been confirmed since char was observed on the tip when the catheter was received at the decontamination lab.The lost of the material (char) could be related to the decontamination process.Char is a physical phenomenon of rf; it can be the normal result of the ablation process.In h6, a secondary preferred component code is "biological and chemical".If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10805338
• Report Number: 2029046-2020-01642
• Device Sequence Number: 19094625
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 03/20/2021
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30369225M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; SMARTABLATE GENERATOR; THERMOCOOL SMARTTOUCH; YELLOW PATCH SENSOR CABLE KIT