MAUDE Adverse Event Report: BIOSENSE WEBSTER INC 7FR LASSO 2515 NAV VARI, 12P; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number	LN122515CT
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a lasso® 2515 nav variable catheter and the biosense webster inc.(bwi) product analysis lab (pal) found white and clear material all over the shaft, leader tubing, two sides of the barrel, and blue clip.Initially, it was reported that during the procedure, the catheter could not deflect.A second catheter was used to complete the operation.No adverse patient consequences were reported.The observed deflection issue has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 1/14/2020, the bwi pal received the device for evaluation.Upon initial inspection, no damage or anomalies observed.Further testing was then performed.During a second visual inspection on 1/15/2020, the bwi pal found white and clear material all over the shaft, leader tubing, two sides of the barrel, and blue clip.The observed foreign material has been assessed as an mdr reportable malfunction.The awareness date has been reset to 1/15/2020.
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure with a lasso® 2515 nav variable catheter and the biosense webster inc.(bwi) product analysis lab (pal) found white and clear material all over the shaft, leader tubing, two sides of the barrel, and blue clip.Initially, it was reported that during the procedure, the catheter could not deflect.The investigational analysis completed (b)(6)2020.The device was inspected, and white material was observed on the shaft, leader tubing, and barrel.However, during the second inspection, the catheter was observed without white material.This could be related to the decontamination process.The contraction mechanism was found working correctly.However, the catheter was unable to deflect.The catheter was observed under x ray and the puller wire with the ferrule was observed slid down inside the tip, causing the deflection issue.A manufacturing record evaluation was performed, and no internal actions were identified.The customer complaint was confirmed.The root cause of the foreign material and the slid down ferrule cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure.However, this cannot be conclusively determined.Manufacture reference no: pc-000625384.

• Brand Name: 7FR LASSO 2515 NAV VARI, 12P
• 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: 9702282
• Report Number: 2029046-2020-00224
• Device Sequence Number: 14059207
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2019

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: 01/28/2022
• Device Model Number: LN122515CT
• Device Catalogue Number: LN122515CT
• Device Lot Number: 30166366L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1