MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO 2515 NAV VARIABLE CATHETER; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number	LN122515CT
Medical Device Problem Codes	Mechanical Jam (2983); Positioning Problem (3009); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device evaluation has been completed.The complaint catheter was inspected and it was found deflection and contraction mechanism activated and stuck.Manufacturing team investigation was performed and revealed that the slug slot was found was found disassembled from its place due to an incorrect amount of polyurethane (pu) on pulley assembly and slug slot, leads to the catheter locked in deflected position or with an over lapping loop/ knotted position.A manufacturing record evaluation was performed, and no internal action related to the reported complaint condition were identified.The customer complaint was confirmed.Based on available analysis results, complaint appears to be caused by internal bwi operations, specifically, the manufacturing process.Additionally, the customer provided a video of the reported malfunction.According to video provided by customer, the tip of the loop did not contact when contraction mechanism was moved.From the video provided, the customers complaint was confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported a patient underwent a cardiac ablation procedure with a lasso¿ 2515 nav variable catheter and the deflection mechanism became stuck.It was initially reported by the customer that at the beginning of the procedure contraction and deflection issues occurred.It was reported that the lasso¿ 2515 nav variable catheter lost its loop contraction ability and couldnt deflect.The catheter was exchanged to continue the case successfully.There were no reports of patient consequence.The reported loss of loop contraction and catheter deflection mechanism were considered not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 1/14/2021, the bwi product analysis lab received the complaint device for evaluation.On 2/8/2020, during product evaluation, the device was found in a fully deflected position with its loop fully contracted.Catheter failed deflection test since it cannot be undeflected and uncontracted (stuck).These findings were assessed as an mdr reportable malfunction.

• Brand Name: LASSO 2515 NAV VARIABLE CATHETER
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11412787
• Report Number: 2029046-2021-00279
• Device Sequence Number: 11643380
• Product Code: DRF
• UDI-Device Identifier: 10846835008272
• UDI-Public: 10846835008272
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: 04/02/2022
• Device Model Number: LN122515CT
• Device Catalogue Number: LN122515CT
• Device Lot Number: 30187661L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1