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

Catalog Number	D134909
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigational analysis completed 11/18/2019.The device was visually inspected and was found in good conditions.During a second visual inspection, ring #11 was found damaged and lifted.The unit was inspected prior leaving the facility, as there are functional tests and inspections at control points based on the process flow diagram of this device, per its part number.This diagram indicates proper manufacturing in accordance with documented specifications and procedures.The catheter outer diameter was measured and was found to be within specifications.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was confirmed.The root cause of the ring damage may be related to the resistance, force, and manipulation of the catheter.According to additional information received, there was resistance or difficulty during insertion and removal of the catheter.Additionally, it was reported that the device was pre shaped.The instructions for use indicate to avoid the usage of excessive force and to advance or withdraw the catheter through the guiding sheath, when resistance is encountered.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a lasso® 2515 nav variable catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found ring#11 damaged and lifted.Initially, it was reported that the lasso catheter had a kink in the shaft and was unable to advance through the sheath.The kink was observed close to the distal end.Caller indicated the catheter was a circular pre- shaped mapping catheter.Resistance was felt both during insertion and removal of the catheter.No exposed wires or sharp rings were observed.Catheter replacement resolved the issue.No adverse patient consequences were reported.The observed kink and resistance with the sheath 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 10/1/2019, 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 11/18/2019, the bwi pal found ring #11 damaged and lifted.However, no kinks in the loop curvature were found.The observed lifted ring has been assessed as an mdr reportable malfunction, as the device integrity was compromised.The awareness date has been reset to 11/18/2019.

• Brand Name: LASSO® 2515 NAV 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: 9474765
• Report Number: 2029046-2019-03983
• Device Sequence Number: 19495319
• Product Code: DRF
• UDI-Device Identifier: 10846835010046
• UDI-Public: 10846835010046
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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: 06/11/2022
• Device Catalogue Number: D134909
• Device Lot Number: 30238682L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1