MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSOSTAR NAV CIRCULAR MAPPING CATHETER; LASSOSTAR¿ CIRCULAR MAPPING CATHETER

Model Number D134702

Device Problems Failure to Sense (1559); Material Separation (1562)

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

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture(s) 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.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.Initial reporter phone:(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and catheter shaft appeared to break while in use inside the patient.It was reported there was an error 116 (20 pole a: catheter sensor error) and the system couldn´t detect the catheter.This catheter was not replaced with another one because the physician wanted to use the same catheter due to air management.They were no noise.The procedure was completed successfully without delay and there was no patient consequence.After the case, the physician took a look at the catheter and saw that the catheter was physically broken.The customer¿s reported sensor error is not considered to be mdr reportable as the potential risk that it could cause or contribute to a serious injury or death is remote.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a lassostar nav circular mapping catheter and catheter shaft appeared to break while in use inside the patient.It was reported there was an error 116 (20 pole a: catheter sensor error) and the system couldn't detect the catheter.This catheter was not replaced with another one because the physician wanted to use the same catheter due to air management.They were no noise.The procedure was completed successfully without delay and there was no patient consequence.After the case, the physician took a look at the catheter and saw that the catheter was physically broken.Device investigation details: a picture was provided by the customer to aid in the investigation.The picture was evaluated following biosense webster's procedures and the evaluation was completed on 22-mar-2023.According to pictures provided by the customer, there is no evidence of the error 116 reported by the customer, also, the shaft of the lassostar catheter was observed broken; this condition is related to the customer complaint.A manufacturing record evaluation was performed, and no internal action related to the reported complaint condition were identified.The customer complaint was not confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Note: h6.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the picture analysis results.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 22-mar-2023, it was noticed some incorrect product information was reported in supplemental (follow-up) medwatch report # 1.Field d1.Brand name was reported as ¿lassostarnav,10p,20mm dia loop¿ and has been updated to "lassostar nav circular mapping catheter".Field d2a.Common device name was reported as ¿lassostar¿ circular mapping catheter¿ and has been corrected to "catheter, electrode recording, or probe, electrode recording".Field g4.Pma/ 510(k) was reported as p030031 and has been corrected to "k211219".

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 lassostar, 10p, dia 20mm loop size approved under 510(k)/pma # k193632.Device investigation continue to be in progress.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).On 20-feb-2023, during investigations of the photos received, it was discovered that the incorrect product details were inadvertently reported in the 3500a initial mdr.It was reported the product involved in this case was actually a lassostar nav catheter.As such, the following fields have been updated to reflect correct product details: d1.Brand name has been updated from ¿thermocool® smart touch® sf uni-directional navigation catheter¿ to ¿lassostarnav,10p,20mm dia loop¿ d2a.Common device name was updated from ¿cardiac ablation percutaneous catheter¿ to ¿lassostar¿ circular mapping catheter¿ d2b.Procode has been updated from ¿lpb¿ to ¿drf¿; d4.Catalog has been updated from ¿d134702¿ to ¿d140402¿; d4.Lot number has been updated from ¿30857168l¿ to ¿30824269l¿; d4.Expiration date has been updated from ¿7/28/2025¿ to ¿6/2/2023¿; d4.Unique identifier (udi) was updated from ¿(b)(4)¿ to ¿(b)(4)¿; h4.Device manufacture date was updated from ¿7/29/2022¿ to ¿6/3/2022¿.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4), on 31-mar-2023 the following correction was processed in the product investigation: it was clarified that the customer complaint regarding shaft broken was confirmed based on the picture received.However, the magnetic issue reported by the customer could not be confirmed.

• Brand Name: LASSOSTAR NAV CIRCULAR MAPPING CATHETER
• Type of Device: LASSOSTAR¿ CIRCULAR MAPPING CATHETER
• 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: 15851213
• MDR Text Key: 307775106
• Report Number: 2029046-2022-02929
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835020342
• UDI-Public: 10846835020342
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2023

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: 06/02/2023
• Device Model Number: D134702
• Device Catalogue Number: D140402
• Device Lot Number: 30824269L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 02/20/2023; 03/22/2023; 03/31/2023
• Supplement Dates FDA Received: 03/17/2023; 03/28/2023; 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• 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