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

Catalog Number D139001

Device Problems Material Separation (1562); Appropriate Term/Code Not Available (3191)

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

Event Date 12/27/2021

Event Type  malfunction  

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).

Event Description

It was reported that an unknown patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a lassostar, 10p, dia 15mm loop size.The lassostar catheter was broken during movements inside the heart.Lassostar catheter was broken during movements inside the heart.Catheter was replaced and the procedure completed successfully.No surgery delayed due to the reported event and catheter replacement solved the problem.The procedure successfully completed with no patient consequences.No other medical intervention was required.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Catheter breakage is mdr-reportable.

Manufacturer Narrative

On (b)(6)2022, bwi received additional information regarding the event.It was reported that the deflection broke and that there were no exposed wires or lifted electrodes.The mechanism of the deflection catheter had broken and the physician was unable to use the catheter deflection.- per internal review of the received information, it was determined that the event is no longer mdr-reportable (as there were no exposed wiring or lifted electrodes to present a risk to the patient).- deflection issue is not mdr-reportable.- the medical device problem code for "material separation" (a0413) no longer applies to this event.- no further reports will be submitted regarding this event.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¿ 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13308328
• MDR Text Key: 287584873
• Report Number: 2029046-2022-00128
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K193632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

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 Catalogue Number: D139001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1