MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D160903

Device Problems Device Contamination with Body Fluid (2317); Material Deformation (2976); Patient Device Interaction Problem (4001)

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

Event Date 10/07/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiovascular procedure with octaray, galaxy, 48p, 3-3-3-3-3, d-curve.The electrode was damaged due to close contact with the qdot micro, bi, tc, d-f.The physician had a steam pop at the right superior vein near to the roof with the qdot micro, bi, tc, d-f.He said he didn¿t feel it at the catheter but that it was audible.And on the carto, there was the error: "leakage current" and the ablation was stopped after 4 sec.The values from the visitag were the following: max.Force 12 gram; init.Impedance: 125 ohm; imp delta: 12 ohm; temp.Max: 54 degrees.After the steam pop, he looked at the qdot micro, bi, tc, d-f catheter tip and there was no charring visible, so he used the same catheter to finish the procedure.The procedure ended successfully.There was no damage or consequences caused to the patient.After the procedure, the physician took out the octaray, galaxy, 48p, 3-3-3-3-3, d-curve and saw a small black point on one electrode and he expressed the concern that it could be a contact from the qdot micro, bi, tc, d-f and octaray, galaxy, 48p, 3-3-3-3-3, d-curve which caused the steam pop.So that is the reason why both catheters should be checked.The surgery was delayed 2 minutes due to the reported event.The procedure was successfully completed.There were no patient consequences.Additional information was received.Generator parameters was an qdot plus mode, temp.Cut off ¿ 65-degree, max power: 90 watt.Max.Temp: 53-degree, impedance initial: 107 ohm, impedance drop: 13, power: 90-watt, max force: 39 grams at the time of steam pop.No sharp or lifted rings.The physician reported that he saw a black point maybe charred electrode.The damage did not result in wires and/or braid being exposed.There was no resistance or difficulty during insertion or removal of the device.There was no detachment.The "current leakage error" was not accompanied by a signal noise/signal loss issue.The current leakage error was assessed as not mdr reportable.This issue was highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety is unaffected by this issue.The electrode was damaged due to close contact with the qdot micro, bi, tc, d-f was assessed as mdr reportable under the octaray, galaxy, 48p, 3-3-3-3-3, d-curve.

Manufacturer Narrative

Initial reporter phone(b)(6).The product has not returned for analysis, however, pictures were provided by the customer.Evaluation is still in progress.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.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: pc-(b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)4) during an internal review on 03-nov-2022, noted a correction to the d4.Expiration date field as it was incorrectly populated as 13-jul-2023 and it should have been 12-jul-2023.Therefore, updated this field.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation (b)(6)2022.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: pc-(b)(4).It was reported, ¿the electrode was damaged due to close contact with the qdot micro, bi, tc, d-f.¿ initially the event was coded under the h6.Medical device problem code of ¿material deformation ((b)(6))¿.During an internal review on (b)(6)2022, it was determined that the code of thrombus/ clot ¿patient device interaction problem (a01)¿ should have also been reported in the 3500a initial to capture the event with octaray, galaxy, 48p, 3-3-3-3-3, d-curve in this complaint.Therefore, updated the h6.Medical device problem code field to include ¿patient device interaction problem (a01)¿.

Manufacturer Narrative

It was reported that a patient underwent a cardiovascular procedure with octaray, galaxy, 48p, 3-3-3-3-3, d-curve.The electrode was damaged due to close contact with the qdot micro, bi, tc, d-f.The physician had a steam pop at the right superior vein near to the roof with the qdot micro, bi, tc, d-f.He said he didn¿t feel it at the catheter but that it was audible.And on the carto, there was the error: "leakage current" and the ablation was stopped after 4 sec.The values from the visitag were the following: max.Force 12 gram; init.Impedance: 125 ohm; imp delta: 12 ohm; temp.Max: 54 degrees.After the steam pop, he looked at the qdot micro, bi, tc, d-f catheter tip and there was no charring visible, so he used the same catheter to finish the procedure.The procedure ended successfully.There was no damage or consequences caused to the patient.After the procedure, the physician took out the octaray, galaxy, 48p, 3-3-3-3-3, d-curve and saw a small black point on one electrode and he expressed the concern that it could be a contact from the qdot micro, bi, tc, d-f and octaray, galaxy, 48p, 3-3-3-3-3, d-curve which caused the steam pop.So that is the reason why both catheters should be checked.The surgery was delayed 2 minutes due to the reported event.The procedure was successfully completed.There were no patient consequences.Additional information was received.No sharp or lifted rings.The physician reported that he saw a black point maybe charred electrode.The damage did not result in wires and/or braid being exposed.There was no resistance or difficulty during insertion or removal of the device.There was no detachment.The "current leakage error" was not accompanied by a signal noise/signal loss issue.The investigation was completed on 16-jan-2023.A picture was received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, a black ring was observed on the carto 3 screen.Although the photo does not provided sufficient information related to the char/thrombus issue reported by the customer, the black ring observed on the carto 3 could be related to the char issue reported, since according to the reported event it could be contact from qdot and octaray which caused the steam pop and resulted the black ring.However, this cannot be conclusively determined.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that an electrode was found bent and another was found damaged.The bending of the device could have happened during the handling, and the damage by the contact with the q dot, according to the complaint description.The catheter was irrigating correctly, and no anomalies nor thrombus were observed.All units are inspected prior to leaving the facility, as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: always place the rocker lever in the neutral position to straighten the catheter tip before insertion or withdrawal of the catheter.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the complaint were found during the review.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: -investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿char¿ and ¿thrombus/clot¿.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the customer¿s reported ¿electrode damaged¿ issue and the biosense webster inc.Product analysis lab finding of a "bent electrode and another was found damaged".-investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the photos provided.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).Initially the event was coded under the h6.Medical device problem code of ¿material deformation (a0406)¿.During additional assessment on 04-jan-2023, this code was updated to device contamination with body fluid (a180103) and the issue was coded as char.

• Brand Name: OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15724037
• MDR Text Key: 307204742
• Report Number: 2029046-2022-02726
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: 10846835021127
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/25/2023

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: 07/12/2023
• Device Model Number: D160903
• Device Catalogue Number: D160903
• Device Lot Number: 30853284L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/04/2022; 11/11/2022; 01/04/2023
• Supplement Dates FDA Received: 11/04/2022; 12/09/2022; 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NGEN GENERATOR; QDOT MICRO, BI, TC, D-F; UNK_CARTO 3