MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	BNI35DFH
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2018
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) has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.(b)(4).
Event or Problem Description
It was reported that a patient underwent an afib ¿ paroxysmal procedure with a thermocool® sf nav bi-directional catheter and thrombus/char issue occurred.The physician reported thrombus or charring was observed at the catheter electrode when the procedure was finished.The thrombus/clot was suspected to be coagulum and the patient did not exhibit any neurological symptoms since the procedure completed.The physician also reported poor signal quality during the case and suspected that there might have been an issue with the insulation of the catheter.However, it was later clarified that no physical damage was observed on the catheter.There was no patient consequence.The issue of coagulum is considered a reportable malfunction, however, the issue of poor signal quality is not a reportable malfunction.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 8/21/2018.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.Based on the received product, the lot number has been verified, however, the catalog number initially reported did not match the reported and received lot number.As such, the following corrections have been processed: catalog has been updated from bni35bfh to bni35dfh.Unique identifier (udi) has been updated from (b)(4) to (b)(4).Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an afib ¿ paroxysmal procedure with a thermocool® sf nav bi-directional catheter and thrombus/char issue occurred.The physician also reported poor signal quality during the case.The investigational analysis has been completed.The device was visually inspected, and it was found in good condition.Electrical test 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.Then, a cool flow pump test was performed, and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.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 cannot be confirmed.Manufacturer's ref.No: (b)(4).

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7600634
• Report Number: 2029046-2018-01666
• Device Sequence Number: 232510
• Product Code: LPB
• UDI-Device Identifier: 10846835003178
• UDI-Public: 10846835003178
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2018

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: 01/30/2021
• Device Catalogue Number: BNI35DFH
• Device Lot Number: 30012509L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 08/21/2018; 08/31/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 08/28/2018; 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1