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

Catalog Number	D134302
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found the tip slightly bent.The ring 1 was found damaged and sharp-edges can be observed as well as the pu was detached.Then, deflection, contraction and expansion test were performed and it was found within specifications, the catheter was deflecting correctly.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint has been confirmed.The root cause of the electrode damaged 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.(b)(6).Manufacturer¿s ref # (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a lasso® nav eco variable catheter for which biosense webster¿s product analysis lab has identified electrode damage with sharp edges.It was initially reported by the customer that during the procedure, the product showed no malfunction, however, after the successful procedure, the physician checked the lasso® nav eco variable catheter and noticed a light kinking between the electrode.There were no patient consequences.On 7/5/2019, additional information was received from the customer indicating the customer did not observe any sharp rings, no exposed wires, no difficulty inserting or removing the catheter and the sheath used was an abbott agilis 11.5 french.The customer¿s reported issue was assessed as not reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 8/20/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found the tip of loop is slightly bent.This was not considered to be mdr reportable.On 9/10/2019, during a second visual inspection, the tip was found slightly bent.Ring 1 was found damaged and sharp-edges can be observed as well as the polyurethane (pu) was detached.These findings were reviewed and assessed the damaged and sharp edges as mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 9/10/2019 and has reassessed this complaint as reportable.

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9114213
• Report Number: 2029046-2019-03690
• Device Sequence Number: 1983979
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113213
• 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
• Report Date (Section B): 07/02/2019

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: 02/21/2022
• Device Catalogue Number: D134302
• Device Lot Number: 30180132L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1