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 Entrapment of Device (1212); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/31/2023

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30919628l number, and no internal actions related to the complaint was found during the review.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: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter left (l-afl) ablation procedure with an octaray, galaxy, 48p, 3-3-3-3-3, d-curve.It was reported that while mapping a left atrial flutter, the octaray, galaxy, 48p, 3-3-3-3-3, d-curve became lodged in the patient's mechanical mitral valve.The physician was able to dislodge the catheter and remove it from the patient.After the catheter was removed, the physician noticed that one of the octaray, galaxy, 48p, 3-3-3-3-3, d-curve splines was missing.The physician asked for a new catheter and the case was continued.The patient's vitals were stable post procedure and they are unaware if the patient is being kept for further observations.Max wattage used was 50 watts in the left atrium, 35 watts max in coronary sinus.Total lesions was 33 lesion in left atrium, 8 lesions in coronary sinus.Total ablation time was 10 min 9 seconds.Total fluid was 400.The adverse event was discovered during mapping of left atrium.Physician¿s opinion on the cause of this adverse event was the patient condition, mechanical valve.Missing spline on octaray, galaxy, 48p, 3-3-3-3-3, d-curve.Transseptal puncture was performed.No evidence of steam pop.The event occurred during mapping prior to ablation.No error messages observed on biosense webster equipment during the procedure.Additional information was received.Patient had a mitral prosthetic value replacement.Patient made a full recovery and was discharged that day.Patient did not require extended hospitalization because of the adverse event.The damage to the device resulted in wires being exposed but they do not believe it resulted in any lifted or sharp rings.Restraints were felt during removal.One of the splines was bent and half of another was removed.Catheter was not pre-shaped.Sheath information was vizigo 8fr sheath.The above catheters and sheaths information was thrown out and they were not able to retrieve it.At this time, this event is assessed as mdr reportable for a serious injury as it is assumed that the broken spline has not been retrieved from the patient.Since the event was life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it was to be considered serious and mdr-reportable.The spline missing was assessed as mdr reportable for a tip fully separated issue.The event was also assessed as mdr reportable for a medical device entrapment with excessive manipulation required issue.

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 01-mar-2023, noted a correction to the 3500a initial.H10.Additional manufacturer narrative included, ¿since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.¿ however, it should have stated, ¿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.¿ corrected the following fields: -h3.Device evaluated by manufacturer? from ¿not returned to manufacturer¿ to ¿no¿ -h3.Reason for non- evaluation was blank to ¿device evaluation anticipated, but not yet begun¿ - h6.Type of investigation from ¿device not returned (b17)¿ to ¿type of investigation not yet determined (b21) -h6.Investigation findings from ¿no findings available (c20) to ¿results pending completion of investigation (c21) -h6.Investigation conclusions from ¿cause not established (d15)¿ to ¿conclusion not yet available (d16)¿.

Manufacturer Narrative

It was reported that a patient underwent an atrial flutter left (l-afl) ablation procedure with an octaray, galaxy, 48p, 3-3-3-3-3, d-curve.It was reported that while mapping a left atrial flutter, the octaray, galaxy, 48p, 3-3-3-3-3, d-curve became lodged in the patient's mechanical mitral valve.The physician was able to dislodge the catheter and remove it from the patient.After the catheter was removed, the physician noticed that one of the octaray, galaxy, 48p, 3-3-3-3-3, d-curve splines was missing.The physician asked for a new catheter and the case was continued.The patient's vitals were stable post procedure and they are unaware if the patient is being kept for further observations.Additional information was received.Patient had a mitral prosthetic value replacement.Patient made a full recovery and was discharged that day.Patient did not require extended hospitalization because of the adverse event.The damage to the device resulted in wires being exposed but they do not believe it resulted in any lifted or sharp rings.Restraints were felt during removal.One of the splines was bent and half of another was removed.The picture investigation was completed on 14-mar-2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, part of a spline of the octaray catheter was observed detached leaving exposed wires.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16461245
• MDR Text Key: 310443968
• Report Number: 2029046-2023-00415
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: 10846835021127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: D160903
• Device Catalogue Number: D160903
• Device Lot Number: 30919628L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC.; SOUNDSTAR ECO GE 10F CATHETER.; THMCL SMTCH SF BID, TC, F-J.
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female