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

Model Number D-1343-01-S

Device Problems Mechanical Problem (1384); Physical Resistance (2578); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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.Since no lot number was provided, no device history record (dhr) review could be performed.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a procedure for atrial fibrillation with a lasso nav variable eco catheter where the shaft of the catheter became twisted.As the physician was attempting to maneuver the catheter from the left atrium to the right atrium, the catheter became twisted.The catheter was then exhibiting some resistance with the sheath, so it was forcibly removed, stripping it and exposing the internal catheter components in the process.At this point, the deflection mechanism stopped functioning, as evidenced by the physicians inability to manipulate the catheter from the thumb controls.The catheter was removed from the patients body and replaced, at which point the case continued without any patient consequences.It was confirmed that the patient was in normal condition with no foreign material lodged inside the patients heart after the event.Multiple attempts have been made to gain additional clarification regarding this event, but none has been made available.The loss of catheter deflection is not a reportable event.Since the catheter cannot deflect or relax properly, it cannot be used, and must be replaced.Additionally, the resistance encountered with the sheath is not reportable.Friction between devices is a known complication of these procedures, and if encountered, the sheath and catheter can be withdrawn from the patient as a unit.The vast majority of electrophysiology procedures utilize multiple device exchanges.The potential that either of these issues could cause or contribute to an adverse event is remove.However, the patients exposure to the internal catheter components creates a risk of thrombus formation, making this an mdr reportable event.

Manufacturer Narrative

Device evaluation results: it was reported that a patient underwent a procedure for atrial fibrillation with a lasso nav variable eco catheter where the shaft of the catheter became twisted.The returned device was visually inspected, and the spine was found damaged with internal parts exposed.The spine was wrapped and showed elongation.The catheter was evaluated for eeprom, carto 3 system performance and sensor functionality.The catheter was recognized by the carto 3 system with no error messages, but only two electrodes were displaying.Eeprom data demonstrates that the catheter was properly calibrated during manufacturing.The outer diameter of the catheter was measured and found within specifications.Per the observed condition, scanning electron microscopy was performed.The results showed evidence of elongation, ductile dimples and mechanical damage at the spine cover.Stretching and/or pulling could have caused these surface characteristics, but the exact cause of the separation cannot be conclusively determined.Cutting as the root cause was discarded, as the separation site did not present with any characteristics typical of this failure mode.No other anomalies were observed.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.During the manufacturing process, all catheters are inspected for visual damage prior to packaging.On-line inspections and functional tests are in place to prevent catheters with this type of damage from leaving the facility.The customer complaint has been verified.Based on the available analysis finding results, the damage on the spine does not appear to be caused by any internal bwi processes, as the device was manufactured in accordance with documented specification and procedures.It could potentially be related to the manipulation of the catheter during the procedure.The instructions for use state that excessive force must not be applied in order to advance or withdraw the catheter through the guiding sheath when resistance is encountered.In addition, extra care should be taken while inserting, aspirating and manipulating the guiding sheath.(b)(4).

Event Description

It was reported that a patient underwent a procedure for atrial fibrillation with a lasso nav variable eco catheter where the shaft of the catheter became twisted.As the physician was attempting to maneuver the catheter from the left atrium to the right atrium, the catheter became twisted.The catheter was then exhibiting some resistance with the sheath, so it was forcibly removed, stripping it and exposing the internal catheter components in the process.At this point, the deflection mechanism stopped functioning, as evidenced by the physicians inability to manipulate the catheter from the thumb controls.The catheter was removed from the patients body and replaced, at which point the case continued without any patient consequences.It was confirmed that the patient was in normal condition with no foreign material lodged inside the patients heart after the event.Multiple attempts have been made to gain additional clarification regarding this event, but none has been made available.The loss of catheter deflection is not a reportable event.Since the catheter cannot deflect or relax properly, it cannot be used, and must be replaced.Additionally, the resistance encountered with the sheath is not reportable.Friction between devices is a known complication of these procedures, and if encountered, the sheath and catheter can be withdrawn from the patient as a unit.The vast majority of electrophysiology procedures utilize multiple device exchanges.The potential that either of these issues could cause or contribute to an adverse event is remove.However, the patients exposure to the internal catheter components creates a risk of thrombus formation, making this an mdr reportable event.

Manufacturer Narrative

On 8/4/2017, the bwi failure 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.Previously, the lot number of the device was unknown.The bwi failure analysis lab was able to ascertain the lot number of the product after its receipt.The lot number is 17626659l.As a result, the lot, manufacturing and expiration date fields have all been updated.Manufacturers reference number: (b)(4).

Manufacturer Narrative

This is a correction to follow up report #1.After further investigation, it was discovered that the lot# identified for this complaint was incorrect.The correct lot# is 17641502l.Therefore, the manufacturing date and expiration dates were updated to correspond to the correct lot.In addition, it was discovered on (b)(6) 2017, that the catheter was received damaged on the spine at approximately 0.5cm from the peek housing/spine cover seal.Internals wires were exposed.The spine was wrapped.The spine cover broken showed elongation.The catheter was sent for scanning electron microscope (sem) analysis on september 22, 2017, to identify the cause of the broken spine cover.Sem results showed evidence of elongation, ductile dimples and mechanical damage at spine cover.Stretching and/or pulling could be related to these surface characteristics, however the exact cause of the separation could not be conclusively determined.Cutting as the root cause was discarded since the separation site did not present any characteristics typical of this failure mode.No other anomalies were observed.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6663800
• MDR Text Key: 78560125
• Report Number: 9673241-2017-00509
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 06/05/2017

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: 01/31/2020
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: UNKNOWN_D-1343-01-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 06/05/2017; 06/05/2017; 06/05/2017
• Supplement Dates FDA Received: 08/18/2017; 10/19/2017; 11/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2017
• 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