MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1343-01-S

Device Problems Entrapment of Device (1212); Device Inoperable (1663); Failure to Advance (2524); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2017

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.Concomitant products: preface sheath (x2), model # 301803m.Smart touch unidirectional catheter (x2), model # d-1336-01-s, lot # 17610471m.Carto 3 system.(b)(4).Even though there were no patient consequences, this event is being conservatively reported, as an excessive amount of manipulation was required to remove the catheter from the patient's body.

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso nav variable eco catheter and suffered medical device entrapment without patient consequence.The lasso catheter was advanced through the preface sheath and into the femoral vein.Once the loop extended beyond the tip of the sheath, the lasso appeared to curl back onto itself, as visualized via carto and fluoroscopy.Upon attempting to uncurl the lasso loop using the push-pull mechanism that opens and closes the loop, the physician found it to be inoperable.The physician then attempted to advance and withdraw the catheter back into the sheath without success.After approximately 15 minutes of maneuvering and manipulating the lasso catheter, the physician pulled the lasso catheter very forcefully back into the preface sheath, then pulled the preface sheath and lasso catheter out of the patient¿s body.Upon inspection, the area of the preface sheath around the distal portholes appeared to be crumpled.There was no ring damage or any other physical damage observed at the distal end of the lasso catheter.The physician speculated that the lasso tip might have exited the preface sheath via one of the portholes, thereby becoming entrapped.Procedure continued using a new lasso catheter and a new preface sheath.At that point, mapping was initiated using the smarttouch catheter.Upon advancing the smarttouch catheter into the right atrium, the distal m1-2 intracardiac electrograms had significant signal interference (noise) on the carto and the recording system.Cables and connections from the smarttouch catheter to the patient interface unit and from the patient interface unit to the recording system were adjusted and the noise issue remained.Catheter cable was replaced and the noise issue remained.Smarttouch catheter was replaced and the noise issue resolved.Procedure was prolonged by 30 minutes.

Manufacturer Narrative

On 4/19/2017, additional information regarding the event and alert dates was received.These fields have been updated to reflect the correct values.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On 5/9/2017, 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.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso nav variable eco catheter and suffered medical device entrapment without patient consequence.The lasso catheter was advanced through the preface sheath and into the femoral vein.Once the loop extended beyond the tip of the sheath, the lasso appeared to curl back onto itself, as visualized via carto and fluoroscopy.Upon attempting to uncurl the lasso loop using the push-pull mechanism that opens and closes the loop, the physician found it to be inoperable.Even though there were no patient consequences, this event was conservatively reported, as an excessive amount of manipulation was required to remove the catheter from the patient's body.Upon receipt, the catheter was visually inspected and it was found in normal conditions.Then per the event, deflection and contraction tests were performed and the catheter passed.No issues were observed, additionally the catheter outer diameter was measured and it was found within manufacture specifications.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.The customer complaint cannot be confirmed.The root cause of the event remains unknown.

• Brand Name: LASSO® 2515 NAV ECO VARIABLE CATHETER
• 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: 6488021
• MDR Text Key: 72658644
• Report Number: 9673241-2017-00273
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17619677L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• 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): Other