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

Catalog Number D134301

Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 08/21/2017

Event Type  Injury  

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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso nav variable eco catheter and suffered a medical device entrapment requiring surgical intervention (extensive physical manipulation and snare).Ablation was performed in the left atrium without issue.During the procedure, while attempting to place the lasso catheter in the precaval vein (superior vena cava), the physician reported feeling resistance, as if the lasso catheter was hooked on something.Attempts to retract the lasso catheter back into the sheath, to include turning the lasso catheter clockwise, were unsuccessful.It was determined that the lasso catheter was entrapped at approximately electrodes 21-22 and that the lasso loop was twisted.The attempt to retrieve the lasso catheter with a snare from the jugular vein side was successful.The lasso catheter was retracted back into the sheath up to electrodes 21-22.At that point, an audible snap occurred.When the lasso catheter and sheath unit were removed from the patient¿s body, material described as ¿red linear tissue¿ was observed to be attached to the lasso catheter loop.No exposed wires or other internal components were observed.Blood pressure remained stable throughout the 30 minute monitoring period.There was no patient consequence or any treatment provided.Physician indicated that the lasso catheter may have become entrapped on a structure that was not visible via imaging (x-ray, intracardiac echocardiography, body surface echocardiography, and computed tomography).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 10/16/2017.The analysis has begun but is not completed at this time.On 10/16/2017 it was discovered that the catheter shaft was cut approximately 1 cm from the loop of the catheter.Internal wires and tubings are exposed.Shaft of the catheter is twisted at two places at the loop.Additional information was received on 10/24/2017 in regard to the returned catheter condition.This condition was not noticed prior to use, however it was noticed upon withdrawal.It is possible there was difficulty withdrawing the catheter that may have caused this damage.First, the physician felt the tension like something was hooked when placing the catheter into the precaval vein.Then he tried to pull it into the sheath by rotating it, but he couldn't.And during pulling the catheter the ring of catheter twisted.This finding is mdr reportable as there are exposed wires and internal components which cases a potential risk to the patient.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso nav variable eco catheter and suffered a medical device entrapment requiring surgical intervention (extensive physical manipulation and snare).The returned device was visually inspected and the shaft was cut approximately 1 cm from the loop of the catheter.Internal wires and tubings were exposed.Shaft of the catheter was twisted in two places and the loop rings was found damaged without sharp edges, however, after the visual inspection, no tissue was attached around its ring, this could have been lost during the decontamination.Additionally, catheter outer diameters were measured and all were found within specifications.The device history record (dhr) was reviewed and no anomalies were found related to this failure mode.Dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Scanning electron microscope (sem) testing was performed showed evidence of a mechanical damage and stress marks on the surface of the spine.It is possible that the damage was generated with an unknown object.No other anomalies were observed.The customer complaint has been confirmed.The root cause of the damages on the device cannot be determined.However, it could be during the handling of the procedure.Manufacturer's ref.No: (b)(4).

• Brand Name: LASSO NAV
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology dr; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: evgeniya degnera ; 33 technology dr; irvine, CA 92618 ; 909839-723
• MDR Report Key: 6870004
• MDR Text Key: 86352568
• Report Number: 9673241-2017-01073
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: (01)10846835009637(11)170406(17)200331(10)17664137L
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2017

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: 03/31/2020
• Device Catalogue Number: D134301
• Device Lot Number: 17664137L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 08/21/2017; 08/21/2017
• Supplement Dates FDA Received: 10/30/2017; 12/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2017
• 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
• Patient Outcome(s): Required Intervention