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

Catalog Number D140402

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection of the returned device according to bwi's procedures.Visual analysis revealed that the shaft was bent with internal components exposed.The condition of the device is potentially attributable to the resistance observed, matching with the event described.No functional tests could be performed, due to the condition does not allow the device to be introduced through a heliostar.All units are inspected prior to leaving the facility to avoid this type of damage.The event reported by the customer was confirmed.It should be noted that product failure is multifactorial.With the available information, it can be concluded that the issue is not associated to the manufacturing process.As part of bwi'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 ref.(b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a lassostar nav circular mapping catheter for which biosense webster¿s product analysis lab (pal) identified the shaft was bent with internal components exposed.It was initially reported by the customer that the lassostar nav circular mapping catheter could not be inserted into the heliostar.It felt like the heliostar lumen was blocked.Due to the pressure on the lasso when inserting it, the lasso is bent in one place.The problem was solved by using a new lasso.The procedure was successfully completed without harm to the patient.The customer¿s reported issue of resistance and bent shaft are not considered to be mdr reportable malfunctions since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 27-dec-2023, the bwi pal revealed that a visual inspection of the returned device found shaft was bent with internal components exposed.These findings were reviewed and assessed the issue of ¿internal components exposed¿ as an mdr reportable malfunction since the integrity of the device has been compromised.

Manufacturer Narrative

On (b)(6) 2024, the e1.Initial reporter details were provided.The appropriate fields have been populated.E1.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).

• 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: 18544368
• MDR Text Key: 333260777
• Report Number: 2029046-2024-00233
• 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
• Report Date: 01/19/2024

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: 11/25/2023
• Device Catalogue Number: D140402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2022
• 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
• Treatment: UNK_HELIOSTAR CATHETER