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

Model Number	D134302
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that an unknown patient underwent an unknown ablation procedure with a lasso® nav eco variable catheter.The catheter's tip was broken inside the lasso loop and could not advance into the vessels.No patient consequences.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The medical device entrapment (inability to advance) is not mdr-reportable.The broken tip is mdr-reportable.
Additional Manufacturer Narrative
On (b)(6)2021, the bwi product analysis lab received the device for evaluation.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).
Additional Manufacturer Narrative
On 8-oct-2021, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a lasso® nav eco variable catheter.The catheter's tip was broken inside the lasso loop and could not advance into the vessels.No patient consequences were reported.Device evaluation details: complaint catheter was inspected and some acceptable wrinkles were found.No other damages or internal components are observed.All units are inspected prior 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.At this time is not possible to determine the root cause of bent tip, however based on the information provided, the condition reported have origin in some place external to the manufacturing environment.A manufacturing record evaluation was performed for the finished device 30343817l number, and no internal action was found during the review.The instructions for use states that sterile packaging and catheter should be inspected prior to use.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: LASSO NAV ECO VARIABLE CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12264630
• Report Number: 2029046-2021-01251
• Device Sequence Number: 17264887
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2023
• Device Model Number: D134302
• Device Catalogue Number: D134302
• Device Lot Number: 30343817L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2021
• Supplement Date Received by Manufacturer: 08/10/2021; 10/08/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 08/17/2021; 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1