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

Model Number	D132704
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
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 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
It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and there was no signal available to monitor the patient¿s heart rhythm.During the procedure, when the thermocool® smart touch¿ bi-directional navigation catheter was connected, the body surface (bs) and coronary sinus (cs) signals were lost.When the catheter was disconnected the electrocardiograms and signals returned.The cable was replaced, but the issue remained.The problem was solved by replacing the thermocool® smart touch¿ bi-directional navigation catheter.The procedure was then continued with no further issues.No patient consequences were reported.The carto 3 system was operating per specifications and was not responsible for the product issue.It was reported that the catheter has been determined to be the root cause of the complaint reported.Originally the reported signal issue was assessed as not mdr reportable as the risk to the patient was low.Additional information was received on july 30, 2020 clarifying that there was signal loss observed on all channels on both the carto 3 system as well as the cardio lab recording system.At that point, there was no signal available to monitor the patient¿s heart rhythm.The catheter was not in the patient¿s body.The additional information provided stating that there was no signal available to monitor the patient¿s heart rhythm was assessed as mdr reportable.The awareness date for this finding is july 30, 2020.
Additional Manufacturer Narrative
On (b)(6) 2020, the product investigation was completed.It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and there was no signal available to monitor the patient¿s heart rhythm.During the procedure, when the thermocool® smart touch¿ bi-directional navigation catheter was connected, the body surface (bs) and coronary sinus (cs) signals were lost.When the catheter was disconnected the electrocardiograms and signals returned.The cable was replaced, but the issue remained.The problem was solved by replacing the thermocool® smart touch¿ bi-directional navigation catheter.The procedure was then continued with no further issues.No patient consequences were reported.Device evaluation details: the device was visually inspected and it was found in good conditions.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The catheter passed electrical specifications.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: 10463392
• Report Number: 2029046-2020-01126
• Device Sequence Number: 16832046
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• 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
• Report Date (Section B): 07/20/2020

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: 02/04/2021
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30339290M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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; NON BWI-CARDIO LAB RECORDING SYSTEM; UNKNOWN BRAND CABLE