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); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 02/10/2016

Event Type  Injury  

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.The device history record (dhr) for the lot number 17355660l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Concomitant products were used during this study: carto 3 system (b)(4), stockert 70 generator (b)(4), and coolflow pump (b)(4).Evaluation methods: no testing methods performed - (b)(4).Results: no results available since no evaluation performed - (b)(4).Conclusion: device discarded by user, unable to follow-up - (b)(4).(b)(4).

Event Description

It was reported that during an afib.Ablation procedure a lasso nav variable eco catheter was entrapped in the inferior vena cava (ivc).When the user completed ablation on left atrium and was mapping pac in the right atrium, the lasso was re-introduced into the ivc and got stuck.It could not been pulled back.The user tried to advance the sheath over the catheter without any luck.The user also tried to torque the catheter handle to open and close the loop at the same time but failed.Finally a vascular surgeon has been brought in.A snare catheter was inserted through a sheath in the internal jugular (ij) vein and looped over the loop of the lasso.The loop, and the shaft of the lasso catheter, was pulled up into the sheath in the ij and out of the body.The loop was cut off the catheter and the rest of the lasso catheter was removed normally through the groin.Procedure for the afib.Ablation was completed and procedure for the ablation of pac has been aborted.No ablation catheter was in the patient at the time of the lasso entrapment.Patient was fully recovered.

• 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 ; 9497893837
• MDR Report Key: 5467900
• MDR Text Key: 39347820
• Report Number: 9673241-2016-00140
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2016

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: 10/31/2018
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17355660L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention