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

Catalog Number	D140401
Medical Device Problem Codes	Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the lassostar nav circular mapping catheter was returned to biosense webster inc for evaluation and the evaluation has been completed.Bwi conducted a visual inspection test of the returned device.The device was visually inspected and was found the shaft was broken in the middle section with electrical wires exposed, however, this damage was not reported by the customer.A manufacturing record evaluation was performed and no internal action was found during the review.No customer complaint was not confirmed since no malfunction was initially reported.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 (b)(4).
Event or Problem Description
It was reported that a patient underwent an 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 broken in the middle section with electrical wires exposed.It was initially reported there this lassostar nav circular mapping catheter was stuck within a heliostar catheter but there was no reported problems with the lassostar nav circular mapping catheter.The customer reported event was not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On (b)(6)-2023, the bwi pal revealed that a visual inspection of the returned device found found the shaft was broken in the middle section with electrical wires exposed.These findings were reviewed and assessed these to be an mdr reportable malfunction.
Additional 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 27-nov-2023, it was noticed the incorrect h6.Medical device problem code was reported in the 3500a initial medwatch report.The incorrect code reported was "adverse event without identified device or use problem (a24).The correct code is "device-device incompatibility (a1702)" and the field has been appropriately updated.
Additional Manufacturer Narrative
**udi related data quality updates only** correction to the initial mdr, incomplete udi was provided.Section d4.Primary udi number has been updated with full udi (b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: LASSOSTAR NAV CIRCULAR MAPPING 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
• 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: 17928253
• Report Number: 2029046-2023-02315
• Device Sequence Number: 12340176
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: (01)10846835020335(11)220801(17)230731(10)30877918L
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K211219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: D140401
• Device Lot Number: 30877918L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 07/11/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/19/2023; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10.5FR 28MM BALLOON ABLAT CATH.
• Patient Sex: Unknown