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

Catalog Number	DLN1215CT
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Jam (2983)
Health Effect - Clinical Codes	Rupture (2208); No Code Available (3191)
Date of Event	01/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 17702333l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an ablation procedure for atrial flutter with a lasso® nav catheter and suffered a cardiac valve rupture requiring surgical intervention.At an unknown phase of the procedure, while a lasso® nav catheter was used, one of the catheter electrodes twisted the chordae tendineae.A cardiac valve rupture occurred, and a thoracic surgery was required.It is unknown if extended hospitalization was required as a result of the adverse event.There¿s no information regarding patient¿s outcome or physician¿s causality opinion.Post-procedure, the patient still feels a dull pain in the chest that prevents him from doing his normal daily activities, he must stay resting at home.The disease has not been cured, recurrent occasionally.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.
Additional Manufacturer Narrative
Additional information was received on (b)(6) 2018.The loop of the catheter got stuck in a fully contracted position and the knob/piston was unable to be turned/pushed up and down.There was difficulty in trying to remove the catheter from the patient¿s body and a valve rupture occurred.There were no physical damages observed at the distal end of the catheter.Physician¿s opinion regarding the cause of the adverse event is that it was procedure and patient condition-related.The outcome of the adverse event is worsened as the surgery caused the patient's body hurts and the patient feels a dull pain in chest.He could not work, and the atrial flutter was not cured.The new information of the loop stuck is also mdr reportable.Manufacturer's ref.No: (b)(4).

• Brand Name: LASSO® NAV CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7786533
• Report Number: 2029046-2018-01953
• Device Sequence Number: 2217880
• Product Code: DRF
• UDI-Device Identifier: 10846835006780
• UDI-Public: 10846835006780
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: DLN1215CT
• Device Lot Number: 17702333L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 32 YR