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

Catalog Number D134302

Device Problems Entrapment of Device (1212); Sharp Edges (4013)

Patient Problems Mitral Insufficiency (1963); No Code Available (3191)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product has not returned for analysis, however, a pictures were provided by the customer.Evaluation is still in progress.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.(b)(4).

Event Description

It was reported that a (b)(6) year old male patient underwent a catheter ablation of persistent atrial fibrillation with a lasso® nav eco variable catheter and suffered a mitral insufficiency requiring surgical repair.During the procedure, the lasso® nav eco variable catheter got caught in the mitral valve which required surgical repair.When the catheter was withdrawn, a piece of the valve was found on the tip of the loop.The customer confirmed that the curve of the catheter was not stuck/jammed in a full deflected position.There was no problem to manipulate the knob/piston.There was difficulty in removing the catheter.There was physical damage observed at the distal end of the catheter described as a broken last electrode.The sheath used was the agilis sheath (abbott).The procedure was not completed.Extended hospitalization was required.The patient had improved.The physician¿s opinion on the cause of this adverse event is that the cause is not clear.It was not patient condition related as it was a relatively young and healthy patient.The procedure was performed with the same conditions as usual.The physician speculated that product malfunction may have been the cause of the event.The biological material was assessed as not reportable.This medical device entrapment and the electrode damage with foreign material were assessed as reportable malfunctions.Since this adverse event may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable.

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The biosense webster inc.(bwi) product analysis lab (pal) received a picture for analysis.The photograph investigation was completed on 11/4/2019.Investigation summary: it was reported that a 57 year old male patient underwent a catheter ablation of persistent atrial fibrillation with a lasso® nav eco variable catheter.During the procedure, the lasso® nav eco variable catheter got caught in the mitral valve which required surgical repair.When the catheter was withdrawn, a piece of the valve was found on the tip of the loop.The customer confirmed that the curve of the catheter was not stuck/jammed in a full deflected position.There was no problem to manipulate the knob/piston.There was difficulty in removing the catheter.There was physical damage observed at the distal end of the catheter described as a broken last electrode.The sheath used was the agilis sheath (abbott).The procedure was not completed.Extended hospitalization was required.The patient had improved.According to the picture provided by the customer, biological material was observed stuck on the lasso® nav eco variable catheter's loop and the first electrode was observed damaged.The customer¿s complaint was confirmed.However, the device has not been returned for analysis.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.A manufacturing record evaluation was performed for the finished device 30253339l number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Investigation summary: it was reported that a 57 year old male patient underwent a catheter ablation of persistent atrial fibrillation with a lasso® nav eco variable catheter.During the procedure, the lasso® nav eco variable catheter got caught in the mitral valve which required surgical repair.When the catheter was withdrawn, a piece of the valve was found on the tip of the loop.The customer confirmed that the curve of the catheter was not stuck/jammed in a full deflected position.There was no problem to manipulate the knob/piston.There was difficulty in removing the catheter.There was physical damage observed at the distal end of the catheter described as a broken last electrode.The sheath used was the agilis sheath (abbott).The procedure was not completed.Extended hospitalization was required.The patient had improved.The device was inspected and it was found that the first electrode from the tip was slightly bent and the shaft just below it was a little twisted.Then, during the second visual, it was confirmed that the first electrode was bent, shaft was a little twisted and it was found with yellowish material on the catheter tip.Further inspection was performed and it was found with electrode damage and the electrode was found without polyurethane (pu) on the edge.Then a magnetic sensor functionality was tested on the carto and the catheter was properly visualized and no errors were observed.Then, an electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Then, deflection, contraction and expansion tests were performed and it was found within specifications.The catheter was deflecting correctly.Then, the catheter outer diameter was measured and it was found within specification.A fourier transform infrared spectroscopy test (ftir) was performed on the yellowish material and the results showed that the foreign material was primarily composed of a biological-base material, presumably human tissue.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint regarding the piece of the valve found on the tip of loop has been confirmed.The root cause of the adverse event remains unknown.The root cause of electrode damage and shaft twisted cannot be related to the manufacturing process since there was 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.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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

The biosense webster inc.Product analysis lab received the device for evaluation on 11/14/2019 and was returned in the condition reported.The initial inspection performed on 11/14/2019 revealed tissue attached to the catheter tip.The first electrode from the tip was slightly bent and the shaft just below it was a little twisted.The initial visual inspection picture was not clear to determine if there was damage to the electrode and therefore, a second inspection was necessary.The catheter was further inspected on 11/21/2019 and it was found with electrode damage and the electrode was found without polyurethane (pu) on the edge.The biological material remains assessed as not reportable.Also, the electrode damage remains assessed as a reportable issue.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.Populated d10.Device available for evaluation?, d10.Is device returned to manufacturer? and d10.Date device returned to manufacturer.Manufacturer's ref.No: (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; 33 technology drive; irvine CA 92618
• MDR Report Key: 9241766
• MDR Text Key: 164244412
• Report Number: 2029046-2019-03816
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (y/n): N
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/01/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2022
• Device Catalogue Number: D134302
• Device Lot Number: 30253339L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/04/2019; 11/14/2019; 12/17/2019
• Supplement Dates FDA Received: 11/13/2019; 12/09/2019; 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS SHEATH (ABBOTT)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 76