MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® NAV ECO CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D134901

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 04/11/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a lasso® nav eco catheter and a sterilization compromised issue occurred.It was reported that the product reached the hospital with suspected sterility violation.The sticker protecting the box has been damaged.No patient involved.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The event was assessed as mdr reportable for a sterilization compromised issue.

Manufacturer Narrative

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 08-may-2023.Without any box damage, only sticker protecting was damaged.It was delivered with damage of the protecting sticker.No physical damage to the outer box or packaging.The device was secured properly in the tray.The device was not used on the patient.The additional information also stated that a picture was provided; however, no picture attached in the complaint file.Therefore, additional attempts have been made to obtain clarification to this discrepancy.However, no further information has been made available.The bwi product analysis lab received the device for evaluation 19-may-2023.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

In the 3500a follow-up #1 it was reported that in the additional information it stated that a picture was provided; however, no picture was attached in the complaint file.Therefore, additional attempts had been made to obtain clarification to this discrepancy.However, no further information had been made available.Additional information was received on 13-jun-2023 stating that the product was returned for evaluation and therefore, they could not provide any picture of it.The device evaluation was completed on 20-jun-2023.It was reported that a patient underwent an ablation procedure with a lasso® nav eco catheter and a sterilization compromised issue occurred.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis revealed no anomalies or damage on the package of the tray, the seal of the pouch was closed in good condition with normal marks of manipulation.No other anomalies were observed that could compromise the sterilization.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved 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) during an internal review on 13-sep-2023, this reported event was reassessed to not reportable as the sterile barrier was intact and low risk to the patient.

• Brand Name: LASSO® NAV ECO 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: 16882696
• MDR Text Key: 314990978
• Report Number: 2029046-2023-00973
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009651
• UDI-Public: 10846835009651
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2023

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 Model Number: D134901
• Device Catalogue Number: D134901
• Device Lot Number: 30889651L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 05/08/2023; 06/13/2023; 09/13/2023
• Supplement Dates FDA Received: 06/02/2023; 07/10/2023; 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• 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