MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY

Catalog Number D124500

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

Patient Problem Stroke/CVA (1770)

Event Date 08/02/2017

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.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: carto 3 system, stockert ep shuttle generator, carto 3 cable (model# cr3434ct lot# 17671703l).(b)(4).This is related to (b)(4), fda report #s 9673241-2017-01018, 9673241-2017-01017 and 9673241-2017-01016 and (b)(4) report number 9612355-2017-00100.

Event Description

It was reported that a male patient underwent an ablation procedure for ventricular tachycardia with a pentaray nav eco catheter, two smarttouch sf catheters, a smarttouch catheter, and a stockert ep shuttle generator and suffered a cerebrovascular accident (cva) requiring unspecified interventions.Access was obtained via retrograde aorta.Left ventricle was mapped with the pentaray catheter.After ablating briefly with the first thermocool smarttouch unidirectional sf catheter, the temperature decreased to 6°c (potentially as low as 4°c).Physician stopped ablating in order to troubleshoot.No errors displayed on the carto 3 system.It was assumed that the temperature issue was secondary to the catheters or cables.Smarttouch sf catheter and cable were exchanged and the issue persisted, as the generator continued to reflect the temperature as 6°c inside and outside of the patient¿s body.It was then assumed that the generator was the issue.Generator was rebooted several times, ensuring that the correct template was chosen.It was noted that the generator was recently sent for preventive maintenance and an upgrade for sf catheters was ordered.It was assumed that there was an issue with the upgrade.Generator was re-set for a non-sf catheter and the second smarttouch sf catheter was exchanged for a non-sf catheter which was inserted and the issue persisted.At this point, the patient decompensated neurologically and a cva was diagnosed.Remainder of procedure was aborted.Stroke unit specialists and neurologists administered unspecified interventions.After stabilization, patient was transferred to the stroke unit.Patient required extended hospitalization as a result of the adverse event for treatment.A few days post-procedure, motor deficit had improved, but unilateral facial paralysis persisted.Most recent status update indicated that the patient outcome was improved.Physician indicated that there were no product defects.Catheter tips were evaluated and no char was observed.Physician¿s opinion regarding the cause of the adverse event was that it was related to procedure and patient condition.It was noted that the cva may have been a result of the 4 catheters being inserted and removed via retrograde aorta and potentially mechanically detaching a piece of aortic tissue or a thrombus.While using the generator was set on power control mode at 30 watts and temperature cut-off was 40°c.Ablation was performed at 30 watts.Initially, the temperature was 20°c, which rapidly declined to 6-8°c, then remained at 6°c.Impedance was approximately 180-220 ohms.It was noted that the system allowed ablation when the temperature fell to 6-8°c, which was below the cutoff value.Due to the patient event the cause of the low temperature was never identified.After further investigation, it was confirmed that the generator displayed less than 10°c and still allowed ablation.It was determined that it was not a catheter or catheter cable issue, but a defective cable connecting the carto 3 patient interface unit and the stockert ep shuttle generator.The defective cable was not exchanged since a cva occurred after inserting and removing the various catheters (pentaray, smarttouch sf x 2, and smarttouch) retrograde via the aorta.This event was originally reported under (b)(4), fda report #s 9673241-2017-01018, 9673241-2017-01017 and 9673241-2017-01016 and (b)(4) report number 9612355-2017-00100.However, additional information was received on august 29, 2017 that ¿inserting and removing four catheters retrograde via the aorta could be the reason for detaching a piece of tissue from the aorta mechanically.¿ therefore, this complaint is also being reported under the pentaray catheter, the first catheter inserted, as it was identified as a potential cause of the adverse event.The awareness date for this product has been reset to august 29, 2017, the date additional information was received.

• Brand Name: PENTARAY
• Type of Device: PENTARAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology dr; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: evgeniya degnera ; 33 technology dr; irvine, CA 92618 ; 909839-723
• MDR Report Key: 6888125
• MDR Text Key: 87206943
• Report Number: 2029046-2017-01013
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D124500
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention