MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. UNK_NAVISTAR THERMOCOOL; CATHETER, ELECTRODE RECORDING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); Stenosis (2263); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a male patient underwent an ablation procedure for persistent atrial fibrillation with a navistar thermocool catheter and possibly suffered pulmonary vein stenosis or phrenic nerve damage.Post-procedure, the patient may have had pulmonary vein stenosis or phrenic nerve damage.Ct scan was performed on the patient to confirm the damage.The physician will decide the action that needs to be taken based on the results.Multiple attempts have been made to gain clarification on this event with no response.There¿s no information regarding the medical/surgical intervention provided, extended hospitalization, patient¿s outcome or physician causality opinion.This event will be conservatively reported under ¿pulmonary vein stenosis¿ and ¿diaphragmatic paralysis¿ as it is not certainly known at this time which of the two patient consequences occurred.These events are considered serious and mdr-reportable.Should any new information be obtained it will be assessed and processed accordingly.

Manufacturer Narrative

On 12/17/2018, additional information about the event and the patient were received.It was reported the product details are unavailable since the procedure occurred sometime in (b)(6) and the catheter and all packaging was discarded.The adverse event was identified post use of the bwi product and the physician¿s opinion is that the cause of the adverse event was that it was procedure-related.The patient had a surgical intervention to widen the pulmonary veins and the patients diagnosis pre-procedure was atrial fibrillation (af).The patient¿s condition is improved and the patient required extended hospitalization since they had to attend for a second procedure to widen the left sided pulmonary veins.The computed tomography (ct) scan showed pulmonary vein stenosis of left sided pulmonary veins.Patient code # 1997 (paralysis) and replaced with # 3191 for surgical intervention.Manufacturer's ref # (b)(4).

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8136508
• MDR Text Key: 129436405
• Report Number: 2029046-2018-02414
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 01/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention