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

Catalog Number D134901

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis completed 8/29/2019.The device was visually inspected and the lasso loop was found pulled off the tip section, leaving broken lead wires exposed, at the distal end of ring #4.Lasso loop was not returned.The biosense webster inc.(bwi) product analysis lab (pal), analyzed the device integrity.The magnetic sensor functionality could not be tested, due to returned condition of device.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint cannot be confirmed.The root cause of the broken lasso loop 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: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a lasso® nav eco catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found exposed wires on the end of ring #4.Initially it was reported that during a radio frequency catheter ablation procedure error code 106 magnetic sensor error code was displayed.Catheter replacement resolved the issue.No adverse patient consequences were reported.The observed magnetic sensor error 106 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 8/27/2019, the bwi pal received the device for evaluation.Upon initial inspection, the lasso loop was observed pulled off from the tip section, leaving broken lead wires exposed from the distal end of ring#4 and the polyurethane seal.During a second visual inspection, the bwi pal found the lasso loop pulled off the tip section, exposing wires.The issue of exposed broken lead wires has been assessed as an mdr reportable malfunction as device integrity was not maintained.No damages to bwi product were reported.Follow up was performed and additional information was received 9/11/2019, indicating damages may have occurred during transportation.The awareness date has been reset to 8/27/2019.

• Brand Name: LASSO® NAV ECO CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9107889
• MDR Text Key: 159750802
• Report Number: 2029046-2019-03686
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009651
• UDI-Public: 10846835009651
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2021
• Device Catalogue Number: D134901
• Device Lot Number: 30148189L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1