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

Model Number	D132704
Medical Device Problem Codes	Insufficient Cooling (1130); Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 ref.# : (b)(4).
Event or Problem Description
It was reported that a patient underwent cardiac ablation procedure for paroxysmal atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter where coagulum occurred.It was reported that coagulum formed on the tip of the thermocool® smart touch® sf bi-directional navigation catheter after about an hour of ablating.There was a sudden temperature rise of 40 degrees.It was at this point that the catheter was removed from the patient and the char was noted.The catheter was exchanged to proceed with the case successfully, without patient harm.Appropriate irrigation settings for the power settings on the generator/pump were confirmed.There was no patient consequence.There were no flow-related issues.The generator was in power control mode 40w default cut offs.The patient was anticoagulated and act greater than 350sec was maintained.Heparinized normal saline was used.There were no lesions over 60sec.The average contact force was not greater than 40 grams., it was intermittently greater then 25gr.The visitag settings were respiration setting, stability range, stability time, force over time, & tag size.Respiration gated, range: 2 mm, time: 3 sec., force over time (fot) 3g at 25% and 2mm tag size, tag index was used for color.The temperature cut-off was exceeded and the system automatically stopped energy delivery.The customer reported high temperature (temperature rise) is not considered to be mdr reportable since the generator stopped delivering rf, the most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.
Additional Manufacturer Narrative
It was reported that a patient underwent cardiac ablation procedure for paroxysmal atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter where coagulum occurred.It was reported that coagulum formed on the tip of the thermocool® smart touch® sf bi-directional navigation catheter after about an hour of ablating.There was a sudden temperature rise of 40 degrees.It was at this point that the catheter was removed from the patient and the char was noted.The catheter was exchanged to proceed with the case successfully, without patient harm.Appropriate irrigation settings for the power settings on the generator/pump were confirmed.There was no patient consequence.Device evaluation details: on 1/27/2021, the bwi product analysis lab received the complaint device for evaluation.The returned device was visually inspected, and it was found in good condition no coagulum was observed on the tip.Per the event, the catheter was tested for generator compatibility and it was found within specifications.The catheter passed the irrigation test.A manufacturing record evaluation was performed for the finished device 30422275m number, and no internal action related to the complaint was found during the review.The customer complaint cannot be confirmed since the device was found working correctly and no evidence of coagulum residues were observed on the tip however, the root cause of the coagulum reported by the customer could be related to the usage of the device during the procedure, however this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) the 6.Medical device problem code of a180103 (device contamination with body fluid) was inadvertently omitted from the 3500a initial medwatch report.The code has now been added.
Additional Manufacturer Narrative
The product investigation was re-open to include details that clarify ¿no char was observed on the catheter tip.¿ manufacturer¿s ref # pc-(b)(4).Initially this event was assessed as mdr reportable for a coagulum on the catheter tip issue.During review on 5/20/2021, a correction was noted to the assessment as this event should have been assessed as char which is not mdr reportable.Char is a physical phenomenon of radio frequency energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.Therefore, the h6.Medical device problem code of ¿device contamination with body fluid¿ is being used to represent the issue.

• Brand Name: THERMOCOOL SMART TOUCH SF 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: 11084234
• Report Number: 2029046-2020-01996
• Device Sequence Number: 16894143
• 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,Followup
• Report Date (Section B): 11/30/2020

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: 08/16/2021
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30422275M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/27/2021; 05/20/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/07/2021; 06/18/2021
• 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; UNSPECIFIED GENERATOR; UNSPECIFIED IRRIGATION PUMP