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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

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 p030031/s078.The device has been reported as discarded, therefore no product investigation can be performed, and 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 reference number: (b)(4).

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle catheter and developed thrombosis.During the procedure, coagulum was seen on the tip of the catheter while ablating.There¿s no indication that medical intervention was provided.It is unknown if the patient required extended hospitalization.Physician causality opinion was not provided.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available, this complaint is being assessed as an ¿adverse event¿ with ¿thrombosis¿ since it seems the coagulum was found inside the patient¿s body.

Manufacturer Narrative

Initially, in the 3500a initial, it was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle catheter and developed thrombosis.During the procedure, coagulum was seen on the tip of the catheter while ablating.There¿s no indication that medical intervention was provided.It is unknown if the patient required extended hospitalization.Multiple attempts had been made to obtain clarification to this complaint.However, no further information had been made available.With the information available, this complaint was assessed as an ¿adverse event¿ with ¿thrombosis¿ since it seemed that the coagulum was found inside the patient¿s body.Additional information was received on 10/9/2020.It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle catheter and coagulum was noticed attached to the tip of the catheter.During the procedure while ablating, impedance risings were observed.The tip of the catheter was checked, and coagulum was noticed.The procedure delayed for a few minutes due to the issue experienced.The delay did not represent a risk to the patient.It is unknown how the issue was resolved; however, it was confirmed that the procedure was successfully completed as normal.In the physician¿s opinion, the amount of coagulum was excessive.The patient did not exhibit any neurological symptom during or post procedure.There was no patient consequence.No physical damage to the catheter was reported.Normal flow values were used.The power was modulated sometimes due to temperatures up to 60 degrees.The noted power was 90w.There¿s no indication that the impedance or temperature cut-off values were exceeded.Ngen generator and ngen pump was used during the case with qmode+ parameters.The target temperature was 60 degrees, the temperature cut-off was at 65 degrees.Low flow set at 2ml/min and high flow at 8ml/min.Heparinized saline was used as fluid irrigation.Activated clotting time (act) was checked every 30 minutes and heparin was administered based on act values.The average contact force was higher than 25gr, and sometimes incidentally higher than 40gr.Per the additional information received stating that the tip of the catheter was checked and coagulum was noticed, this event was reassessed from a ¿thrombosis¿ serious injury to a malfunction.Therefore, b1.Is product problem, h1.Type of reportable event, h 6.Patient codes and h 6.Device codes fields have been populated.The high impedance and high temperature issues were assessed as not mdr reportable.Although the incidence of high impedance and high temperature occurred, there¿s no indication that the user selected impedance and temperature cut-off values were exceeded.The potential risk to the patient was remote.The high force issue was assessed as not mdr reportable.The incidence of high force was highly detectable when occurring.The potential risk to the patient was remote.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).

Manufacturer Narrative

The device evaluation was completed on 11/20/2020.It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle catheter.During the procedure while ablating, impedance risings were observed.The tip of the catheter was checked, and coagulum was noticed.The procedure delayed for a few minutes due to the issue experienced.The delay did not represent a risk to the patient.It is unknown how the issue was resolved; however, it was confirmed that the procedure was successfully completed as normal.In the physician¿s opinion, the amount of coagulum was excessive.The patient did not exhibit any neurological symptom during or post procedure.There was no patient consequence.No physical damage to the catheter was reported.The power was modulated sometimes due to temperatures up to 60 degrees.There¿s no indication that the impedance or temperature cut-off values were exceeded.The average contact force was higher than 25gr, and sometimes incidentally higher than 40gr.Upon receipt, the catheter was visually inspected and it was found in normal conditions: no trails of thrombus were observed.Then, per the complaint, nmarq generator compatibility was tested and no temperature issues were detected.Also, an irrigation test was performed and the catheter passed the test: no irrigation issues were detected.Also, sensor functionality was tested on carto 3 and the catheter was found in specification.A manufacturing record evaluation was performed for the finished device number and no internal action related to the complaint was found during the review.The customer complaint cannot be duplicated as intended.The device was found working correctly and no evidence of thrombus residues were observed on the catheter.The device was found working in 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).

Manufacturer Narrative

Manufacturer's reference number: (b)(4).This event was reported as assessed as mdr reportable for a coagulum 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, updated under ¿h6.Medical device problem code¿ to ¿device contamination with body fluid¿.

• 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: 10618435
• MDR Text Key: 209828142
• Report Number: 2029046-2020-01381
• 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
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2020
• Device Catalogue Number: D139505
• Device Lot Number: 30267588L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/09/2020; 11/20/2020; 05/20/2021
• Supplement Dates FDA Received: 11/05/2020; 12/05/2020; 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NGEN GENERATOR; NGEN PUMP
• Patient Outcome(s): Life Threatening