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

Model Number D134301

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent cardiac ablation procedure with a lasso® nav eco variable catheter where knotted loop occurred.After pulmonary vein isolation (pvi) when the catheter was pulled to the inferior vena cava (ivc) to isolate the superior vena cava (svc), it was caught by the structure in the right atrium (ra) and then the lasso® nav eco variable catheter was tied (knotted).The sheath was not inserted, but the catheter was removed as it was.It did not remain in the patient¿s body, and there was no effect on the patient.The procedure was completed without any problems.There was no particular problem in the post-case examination.The physician¿s commented that if the catheter was caught by a structure in the ra when it was lifted, the lasso® nav eco variable catheter was tied.Since the event is attributable to the fact that lasso® nav eco variable catheter was concluded, there is a causal relationship.However, there was no product defect report from the doctor, and the doctor said that there was no problem with the product itself and the product was rotated too much by his own operation.There was no report of patient consequence nor extended hospitalization.Based on the event description the device was removed without additional intervention.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure with a lasso® nav eco variable catheter where knotted loop occurred.After pulmonary vein isolation (pvi) when the catheter was pulled to the inferior vena cava (ivc) to isolate the superior vena cava (svc), it was caught by the structure in the right atrium (ra) and then the lasso® nav eco variable catheter was tied (knotted).The sheath was not inserted, but the catheter was removed as it was.It did not remain in the patient¿s body, and there was no effect on the patient.The procedure was completed without any problems.There was no particular problem in the post-case examination.Device evaluation details: on (b)(6) 2020, the bwi product analysis lab received the complaint device for evaluation.The device evaluation has been completed.The device was visually inspected, and it was returned with the sheath.The lasso loop was observed to be deformed.The catheter¿s outer diameter was measured, and no anomalies were observed.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint was found during the review.The customer complaint was confirmed.The root cause of the lasso deformed cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the manipulation and handling of the device during the procedure, however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Correction: it was noticed that the ¿unknown sheath¿ was inadvertently omitted from the 3500a initial medwatch.It has been added to field d11.Concomitant med.Products.Manufacturer¿s ref # (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: 10394572
• MDR Text Key: 202568551
• Report Number: 2029046-2020-01032
• 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
• Report Date: 07/15/2020

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: 03/17/2023
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 30375505L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SHEATH.