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

Model Number	D134903
Medical Device Problem Codes	Signal Artifact/Noise (1036); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction procedure with a lasso® nav eco catheter, and the biosense webster, inc.Product analysis lab observed a lasso loop broken issue.Initially the lasso® nav eco catheter (lot 30499595l) had a signal noise which occurred at the 7-8, 9-10 on both the carto 3 system and the lab2 when placed in the patient¿s body.The cable was reconnected and changed but the issue continued.The lasso® nav eco catheter was changed and the issue resolved.The procedure could be continued and completed without patient consequence.The signal noise issue was assessed as not mdr reportable.The risk to the patient was low.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2021 the returned sample revealed damage at the tip area on the lasso® nav eco catheter as internal components were exposed and electrodes 1 and 2 were forcefully moved from their original place.Multiple attempts have been made to obtain clarification to this returned condition.However, no further information has been made available.This returned condition was assessed as mdr reportable for a lasso loop broken issue.The awareness date for this reportable lab finding was (b)(6) 2021.
Additional Manufacturer Narrative
(b)(6).The bwi product analysis lab received the device for evaluation 03-sep-2021.The device evaluation was completed on (b)(6) 2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and electrical evaluation of the returned device.Visual analysis of the returned sample revealed damage at the tip area on the lasso nav eco catheter, internal components were exposed and electrodes 1 and 2 were forcefully moved from their original place.A follow-up activity was opened to verify if it was a pre-existing condition and no response was returned, therefore it's possible that this damage was done to the catheter after the procedure by an unknown force, possibly by poor handling of the device but this cannot be conclusively determined.The electrical test could not be performed as the damage done to the catheter's electrodes made it unable to further analyze it.A manufacturing record evaluation was performed and no internal action was found during the review.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.To minimize ecg noise, the following guidelines should be followed.Ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

• Brand Name: LASSO® NAV ECO 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12858749
• Report Number: 2029046-2021-02015
• Device Sequence Number: 14540693
• Product Code: DRF
• UDI-Device Identifier: 10846835009675
• UDI-Public: 10846835009675
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

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: 01/21/2024
• Device Model Number: D134903
• Device Catalogue Number: D134903
• Device Lot Number: 30499595L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• 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: 7FR DEF LASSONAV SH,12P,20MM,D; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNK_CARTO 3
• Patient Sex: Unknown