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

Model Number D134301

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Rupture (2208)

Event Date 05/06/2021

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a right ventricle outflow tract (rvot) ablation procedure on which a medical device entrapment occurred requiring surgical intervention.Patient also suffered cardiac valve rupture requiring tricuspid valve replacement.While mapping with the lasso® nav eco variable catheter, the tip of the catheter became entrapped just below the tricuspid valve on the septal side and required additional tools (snare) to be removed it.The physician was advised that the lasso catheter is contraindicated for use in the ventricles.The loop of the lasso was still adjustable, but the tip was caught and was fixed in a ¿hook¿ like shape.The steering mechanism appeared to be functioning well.Anti-clockwise rotation for five turns was tried, then rotating back to original position and then clockwise for five turns before returning to original position was tried but none of these steps freed the catheter.The sheath on which the catheter was in was also advanced but could not be advanced beyond the distal four electrodes which were in a hook like shape.An interventionalist consultant was called for advice and the handle end of the lasso was cut off to allow changing of sheath to use specialist extraction kit including snares.Eventually with the assistance of the interventionalist consultant, the lasso was removed using a snare at the proximal electrodes and a snare at the distal tip and pulling towards the inferior vena cava (ivc).A significant chunk of tissue was attached to the tip, which appeared to have perforated the tissue and then curled back on itself and embedded in the same bit of tissue; however, the patient remained hemodynamically stable throughout and after.An echo scan done immediately after the lasso extraction showed that the tricuspid valve was functioning normally and appeared to be intact, and no pericardial effusion noted; therefore, no perforation was confirmed.The patient was admitted to the cardiac care unit (ccu) ward for monitoring and to have a repeat echo.The results for the repeated echo were not provided.The tissue recovered from the end of the catheter was sent off for histological analysis.Analysis results were not provided.Patient required tricuspid valve replacement.Post procedure, extensive damage of lasso catheter was observed, however, this was very likely to have been caused by the extensive snaring and manipulation of the catheter during the many extraction attempts.Additionally, in order to facilitate the removal of the original sheath and the deployment of different sheaths and snares, the handle of the lasso was deliberately cut off.The lasso was functioning perfectly well up until the incident occurred.Given the extensive damage done to the catheter during the extraction procedure it will be impossible to tell what state the catheter was in pre procedure.The sheath used was an abbott med agilis 8.5fr sheath.Since the event required surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, this is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 6/3/2021, bwi received additional information regarding the event.The adverse event discovered during use in the mapping phase of procedure.The physician¿s opinion on the cause of this adverse event: physician opinion is that event occurred due to lasso catheter becoming entangled in valve.Surgical intervention performed: pt required tricuspid valve replacement (tissue).The patient required extended stay because of valve replacement surgery.The patient outcome was reported as fully recovered.Due to the prolonged hospitalization, the checkmark in section b2 and the health effect - impact code in h6 have been updated accordingly.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 12-aug-2021, the bwi product analysis lab received the device for evaluation.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 18-aug-2021, the product investigation was completed.It was reported that a patient underwent a right ventricle outflow tract (rvot) ablation procedure on which a medical device entrapment occurred requiring surgical intervention.Patient also suffered cardiac valve rupture requiring tricuspid valve replacement.While mapping with the lasso® nav eco variable catheter, the tip of the catheter became entrapped just below the tricuspid valve on the septal side and required additional tools (snare) to be removed it.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual inspection revealed that the lasso catheter was damaged from tip: several electrodes, cables and catheter material were exposed.Also, the handle area was cut and it was not returned.The catheter was stucked into a medtronic's flexcath advance sheath.The customer stated that the physician "had been advised that the lasso catheter is contraindicated for use in the ventricles".Regarding the handle missing condition, it was stated that "an interventionalist consultant was called for advice and the handle end of the lasso was cut off to allow changing of sheat".The handle was removed during procedure.The stuck catheter condition could not be evaluated since the catheter's tip was too damaged to be analyzed.A manufacturing record evaluation was performed for the finished device 30455289l number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis that could be related to the adverse event.The instructions for use (ifu) have the following recommendations: to avoid potential damage to anatomical structures, do not attempt to pull the catheter, or withdraw it into the sheath, with the loop in a contracted position.The loop should be fully relaxed (handle grip rotated fully to the left) to minimize tension applied to the nitinol structure.Do not introduce the lasso¿2515navecovariable catheter tip folded into the guiding sheath.The lasso¿2515navecovariable catheter is recommended for use with an 8 f guiding sheath.Do not use the lasso¿2515navecovariable catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25 mm in diameter.Physician opinion is that event occurred due to lasso catheter becoming entangled in valve.The instructions for use (ifu) states the following contraindications, which are related to physician's opinion: the transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.The retrograde approach is contraindicated because of risk of entrapping the lasso¿2515 nav eco variable catheter in the left ventricle or valvular apparatus.The lasso¿2515 nav eco variable catheter is not recommended for use in the ventricles.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: LASSO NAV ECO VARIABLE 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
• MDR Report Key: 11883183
• MDR Text Key: 256444787
• Report Number: 2029046-2021-00825
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2023
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 30455289L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 06/03/2021; 08/12/2021; 08/18/2021
• Supplement Dates FDA Received: 06/17/2021; 08/17/2021; 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT MED AGILIS 8.5FR SHEATH.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention