MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSOSTAR NAV CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D140401

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lassostar nav circular mapping catheter and an internal components issue occurred.At the beginning of the procedure, when introducing the lassostar nav circular mapping catheter into the hs catheter, it felt some resistance which was relieved by moving the inflation knob in the handle.Then in the middle of the procedure, after 2 veins were ablated, the guidestar sheath (distributed device) steering mechanism broke and it was not possible to curve it anymore.They replaced the guidestar sheath for a new one.Lastly, when removing catheters from the patient, the lassostar nav circular mapping catheter broke and came out without the "lasso" with the 10 electrodes.Fragments were generated and were removed easily without additional intervention.The fragments are inside the heliostar catheter.It was only confirmed with xray.The procedure was delayed 10 minutes.The procedure was successfully completed.It was unknown if there was any medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required.There was no patient consequence.It was part of a clinical study.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The issue described as resistance was assessed as non mdr reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The issue of the lassostar nav circular mapping catheter broke and came out without the "lasso" with the 10 electrodes was assessed as a mdr reportable internal components issue.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The product has not returned for analysis, however, a picture was 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: (b)(4).

Manufacturer Narrative

Additional information was received on 03-jul-2023.Heliostar catheter was able to be inserted inside guidestar sheath without any problem.It was possible to withdraw the heliostar catheter completely through the guidestar sheath and out of the patient.No problem.No visible damage to the guidestar sheath.Prior to pulling the balloon back into the sheath, the user extend (collapse) the balloon and allowed 30 seconds before slowly withdrawing the catheter back into the sheath.The sheath and balloon were not removed simultaneously.Medical intervention was not required.The irrigation was reduced to 5ml/min.The catheter was in a deflected state.The balloon was extended (collapsed).It was possible to pass a wire or lassostar through the balloon.A y-adaptor was connected to the heliostar catheter.There was no occlusion when irrigating the heliostar catheter.The sheath / heliostar was in a deflected state.It was not possible to see the lassostar electrodes, they stayed inside the heliostar catheter.There was some resistance during insertion, and at the end of the procedure there was high resistance at retraction.Then the lassostar came out without the ¿lasso¿ with the 10 electrodes.The heliostar catheter was x-rayed and the 10 electrodes were visible at the handle area.The heliostar catheter was not narrowed, partially blocked, or completely blocked.There was no medical or surgical intervention.The patient was not hospitalized.No consequences.The procedure was completed successfully.There will be a relook procedure within 4-6 months according to protocol.So further monitoring is possible.There were no other devices besides the guidestar that were inserted through the sheath at the time of the event.Only the heliostar was through the guidestar at that time.The physician believes it was first removing the heliostar from the sheath, still with the lassostar inside and then the nurse feeling the resistance while retracting the lassostar and then finding a broken lassostar after pulling it out.The lassostar was pulled out.Clarification was provided for the statement, ¿the lassostar broke and came out with the lassostar with the 10 electrodes¿.It should have stated, ¿the lassostar broke and came out without the lasso with the 10 electrodes¿.Therefore, the issue was reassessed from a mdr reportable internal components exposed issue to a mdr reportable broken tip issue.The h6.Medical device problem code remains the same as break (a0401).In addition, the nurse information was provided.Therefore, updated e.Initial reporter section.The bwi product analysis lab received the device for evaluation on 11-jul-2023.The investigation was completed on 14-jul-2023.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lassostar nav circular mapping catheter and a broken tip issue occurred.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the loop of the lassostar nav catheter was completely detached from the rest of the tip, also, exposed wires were observed.The detached condition observed on the device could be related to the resistance felt during the procedure.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 device was returned to biosense webster (bwi) for evaluation.A visual inspection of all features was performed following bwi procedures.Visual inspection was performed, and the loop of the lassostar nav catheter was observed completely detached from the rest of the tip, leaving internal components exposed.The detached condition observed on the device could be related to the resistance felt during the procedure; however, this can not be conclusively determined.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following warning and precaution: prior to removing or repositioning the catheter, use direct imaging guidance such as fluoroscopy to confirm that the spine assembly is not entangled with another catheter or with an anatomical structure.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: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported ¿broken tip¿ issue.-investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to photo 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).

• Brand Name: LASSOSTAR NAV CIRCULAR MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 17221604
• MDR Text Key: 318209856
• Report Number: 2029046-2023-01414
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: 10846835020335
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K211219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

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: 08/12/2023
• Device Model Number: D140401
• Device Catalogue Number: D140401
• Device Lot Number: 30888254L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2022
• 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: 10.5FR 28MM BALLOON ABLAT CATH; GUIDESTAR SHEATH; UNKNOWN BRAND SHEATH