MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSOSTAR¿ NAV CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D140402

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lassostarnav,10p,15mm dia loop.It was reported that during a procedure, while in the right veins, the lasso "catheter kept getting stuck with the balloon." they reported that when they pulled the catheter back, it got frayed and the electrodes broke off in the sheath.To troubleshoot the medical team pulled out the catheter.They opened a new lasso catheter, but it was experiencing resistance, the physician felt uncomfortable proceeding with the replacement lasso catheter, so they replaced it with a cryo-catheter.The issue was resolved, and the procedure is being continued.No patient consequences were reported.The damage resulted in wires and/or braid being exposed.They weren¿t sure if the damage resulted in any lifted or sharp rings.The physician removed the detached section.Video attached on email for picture purposes.The sheath / heliostar was in the deflected state.3 rings were observed with damage.The resistance was felt during retraction of the catheter.The reported lot number 30941558l was the first used catheter that had electrodes broke off in the sheath issue.Resistance with lumen is not mdr-reportable.Broken tip is mdr-reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.Additionally, a video of the complaint device was also received.The analysis has begun for all available items (video and physical device) but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 2-mar-2023, the product investigation was completed.On 14-mar-2023, the video analysis was completed.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lassostarnav, 10p, 15mm dia loop.It was reported that during a procedure, while in the right veins, the lasso "catheter kept getting stuck with the balloon." they reported that when they pulled the catheter back, it got frayed and the electrodes broke off in the sheath.To troubleshoot the medical team pulled out the catheter.They opened a new lasso catheter, but it was experiencing resistance, the physician felt uncomfortable proceeding with the replacement lasso catheter, so they replaced it with a cryo-catheter.The issue was resolved, and the procedure is being continued.No patient consequences were reported.Device evaluation details: a video was received for evaluation following biosense webster's procedures.According to the video provided by the customer, the device was broken in two pieces at the shaft near to the tip section, also, the loop was observed with a peeling condition.The device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.No additional tests could be performed due to the damaged presented in the device.Visual analysis revealed that the shaft was broken in two parts.The tip of the device showed damaged electrodes with internal components, an electrode was lifted from one of its sides, as well as the broken tip.A manufacturing record evaluation was performed for the finished device [30941558l] number, and no internal actions related to the reported complaint condition were identified.The damage reported could be related to the interaction between both devices during the procedure and removal.The instructions for use (ifu) contain the following recommendations: do not use excessive force to advance or withdraw the catheter if resistance is encountered.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) the d1 brand name was mistakenly represented.The g4 section pma/510(k) number was mistakenly omitted from the initial report.Both d1 and g4 have been updated.

• Brand Name: LASSOSTAR¿ NAV CIRCULAR MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16439382
• MDR Text Key: 310367162
• Report Number: 2029046-2023-00379
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835020342
• UDI-Public: 10846835020342
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

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 Model Number: D140402
• Device Catalogue Number: D140402
• Device Lot Number: 30941558L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: CRYO CATHETER.; HELIOSTAR.; LASSO NAV CATHETER.