MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR DS ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NS7TCF8L174HS

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a navistar¿ ds electrophysiology catheter and a clot issue occurred.It was reporting that a lot of clotting on the tip of the navistar¿ ds electrophysiology catheter was observed after the ablation.Physician considered the amount of clot was excessive.The procedure was successfully completed.No patient consequences occurred.Patient did not exhibit any neurological symptom since the procedure was completed.No error message was observed.No issues related to temperature nor flow were reported.The generator was used in power control mode at 70 watts.The temperature cut-off was at 48 degrees.The duration of the ablation was 120 seconds.Heparinized normal saline was used as irrigation fluid.The clot issue was assessed as mdr reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 2/26/2021.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).

Manufacturer Narrative

It was reported that a patient underwent a procedure with a navistar¿ ds electrophysiology catheter and a clot issue occurred.It was reporting that a lot of clotting on the tip of the navistar¿ ds electrophysiology catheter was observed after the ablation.Physician considered the amount of clot was excessive.The procedure was successfully completed.No patient consequences occurred.Patient did not exhibit any neurological symptom since the procedure was completed.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted visual inspection and generator testing of the returned device.Visual analysis of the returned sample revealed that clot excerpts on the tip were observed on the navistar¿ ds electrophysiology catheter.The catheter was connected to the generator and temperature/impedance values were observed within specifications.Generator testing was performed in accordance with bwi procedures.A manufacturing record evaluation was performed for the finished device 30454372m number, and no internal actions related to the reported complaint condition were identified.As part of biosense webster¿s quality process all devices are manufactured, inspected, and released to approved specifications.The product instructions for use (ifu) contain the following instruction: in the event of a generator cutoff (impedance or temperature), the catheter must be withdrawn and the tip electrode inspected for coagulum before rf current is reapplied.Remove any coagulum with a sterile gauze pad dampened with sterile saline.Note: during product evaluation, the lot number was identified as ¿30454372m¿.As such, field d 4.Lot has been populated with this information.Lot number verification also allowed the manufactured date and expiration date to be provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with respective information.The h6.Component code of "appropriate term/code not available (g07002)" used to represent "biological and chemical (g01)" if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

Manufacturer's reference number: (b)(4) this event was assessed as mdr reportable for a clot issue.During review on(b)(6) 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, populated under ¿h6.Medical device problem code¿ ¿device contamination with body fluid¿.

• Brand Name: NAVISTAR DS ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11370046
• MDR Text Key: 233576891
• Report Number: 2029046-2021-00219
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000603
• UDI-Public: 10846835000603
• Combination Product (y/n): N
• PMA/PMN Number: P010068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: NS7TCF8L174HS
• Device Catalogue Number: NS7TCF8L174HS
• Device Lot Number: 30454372M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR KIT-WW; UNK_SMARTABLATE PUMP