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

Catalog Number LN122515CT

Device Problems Bent (1059); Entrapment of Device (1212); Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Date 08/01/2017

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.Dhr review: the device history record (dhr) for the lot number 17158054l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant products: preface sheath 8 french, us catalog #: 301803m, lot #: unknown.Manufacturer's ref.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a lasso navigational variable eco catheter and suffered a medical device entrapment requiring surgical intervention.While mapping in the left atrium, the lasso traversed the mitral valve and became entrapped in the papillary muscles.Physician was unable to retrieve the catheter manually.Patient was transferred to the operating room for open heart surgery.Patient required extended hospitalization for recovery from surgery as a result of the adverse event.Patient fully recovered.It was noted that atrial fibrillation was not terminated with this procedure.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related, as medical device entrapment is a complication of catheter ablation.Lasso loop was stuck in a fully contracted position.Knob/piston could not be turned and/or pushed up and down.There was difficulty removing the catheter.After multiple attempts to remove the catheter manually, there was an issue with the tip of the catheter.The damage was physical, but nothing was exposed from the internal components resulting from extensive manipulation.There was ring or other physical damage observed at the distal end of the catheter.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

Additional information was received on october 12, 2017 stating that the product was disposed of and they were unable to retrieve the catheter because the surgeons had cut it into 4 pieces to pull it out from the mitral valve.Device evaluated by manufacturer? fields have been updated.No product failure analysis can be conducted and device malfunction cannot be confirmed.Manufacturer's ref.No: (b)(4).

• Brand Name: LASSO
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 6871083
• MDR Text Key: 86430266
• Report Number: 9673241-2017-01078
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K081258
• 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
• Report Date: 08/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: LN122515CT
• Device Lot Number: 17158054L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 120