MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE; SIMILAR DEVICE D134801, PMA # P030031/S078

Catalog Number D139505

Device Problems Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch® sf bi-directional navigation catheter approved under 510(k)/pma # p030031/s078.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Note: the date of event was not provided.Manufacturer's ref.#: (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle where coagulum on the tip occurred.There was coagulum on tip during ablation.No error messages presented on the system.No temperature or flow issues.Ablation performed in qmode+ (90w power, 4 sec, with corresponding flow rates between 8 and 15 ml/min, pre ablation high 2 sec).Patient was anticoagulated and activated clotting time (act) maintained above 300.The average contact force was not above 40gr.Heparinized normal saline used.Qmode and visitag used for force visualization.There was no patient consequence.The patient did not exhibit any neurological symptoms since the procedure was completed.The physician considers the amount of coagulum excessive (based on their clinical experience).

Manufacturer Narrative

On (b)(6) 2020, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle where coagulum on the tip occurred.There was coagulum on tip during ablation.No error messages presented on the system.No temperature or flow issues.There was no patient consequence.The patient did not exhibit any neurological symptoms since the procedure was completed.The physician considers the amount of coagulum excessive (based on their clinical experience).Device evaluation details: the device evaluation has been completed.The returned device was visually inspected and it was found in normal conditions.Per the event, the catheter was tested for nmarq compatibility and it was found 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.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.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

On 1/7/2021, the date oe event was received as (b)(6) 2020 and field b3.Date of event has been populated.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 ref # (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: QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE
• Type of Device: SIMILAR DEVICE D134801, PMA # P030031/S078
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10760217
• MDR Text Key: 227970601
• Report Number: 2029046-2020-01599
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2021
• Device Catalogue Number: D139505
• Device Lot Number: 30343701L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/30/2020; 12/08/2020; 01/07/2021; 05/20/2021
• Supplement Dates FDA Received: 11/20/2020; 01/04/2021; 01/10/2021; 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; NGEN GENERATOR.; NGEN PUMP, EU CONFIGURATION.