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	Manufacturing, Packaging or Shipping Problem (2975); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with lassostar nav circular mapping catheter for which biosense webster¿s product analysis lab (pal) identified some rings damaged (i.E.Dented and sharp edges), the tip section was observed to be damaged, and internal components were exposed.Initially it was reported that the lassostar nav circular mapping catheter wire was kinked directly out of the package.The catheter was replaced and the next one was also kinked.When the catheter was replaced again, the issue resolved.All catheters were from the same lot number.No patient consequence reported.Additional information was received.No physical damage to the outer box or packaging.No pictures available.Was not able to take pictures during the procedure.The device was secured properly in the tray.No damage to the device due to any part of the packaging being damaged.Everything was discarded except the catheters.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 22-sep-2023, a bent was observed on the shaft.Additionally, some rings were observed to be damaged (i.E.Dented and sharp edges), the tip section was observed to be damaged, and the internal components were exposed.This event was originally considered non-reportable, however, bwi became aware of some rings were observed to be damaged (i.E.Dented and sharp edges), the tip section was observed to be damaged, and the internal components were exposed on 22-sep-2023 and have assessed this returned condition as reportable.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 25-aug-2023.The device evaluation was completed on 22-sep-2023.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that a bent was observed on the shaft.Additionally, some rings were observed to be damaged (i.E.Dented and sharp edges), the tip section was observed to be damaged, and the internal components were exposed.This condition could be related to excessive force or manipulation; however, this cannot be conclusively determined.No other damages or abnormalities were found, the original package was not returned to the analysis lab.The bent condition noted on the device may have been related to the customer complaint and may have appeared to have been caused by excessive force and handling applied to the device; however, none of those can be conclusively determined.The customer complaint was confirmed.All units are inspected prior to 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.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the customer¿s reported ¿kinked¿ issue.Investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Analysis finding of the ¿ring damage¿.Manufacturer's reference number:(b)(4).
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 (01)10846835020335(11)221019(17)231018(10)30929201l.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: 17964804
• Report Number: 2029046-2023-02376
• Device Sequence Number: 6565772
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: (01)10846835020335(11)221019(17)231018(10)30929201L
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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: 10/18/2023
• Device Catalogue Number: D140401
• Device Lot Number: 30929201L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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: LASSOSTARNAV,10P,15MM DIA LOOP.
• Patient Sex: Unknown