MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D128211

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

Patient Problem Stroke/CVA (1770)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.We are working on the device history record (dhr), once we get more information it will be submitted in the supplemental.Concomitant products: thermocool smarttouch bidirectional sf catheter (model# d-1348-01-s, lot# 30001966l); soundstar eco catheter (model# m-5723-17, lot# e8105723); lasso nav catheter (model# d-1343-01-s, lot# 30019675l).Manufacturers ref no: (b)(4).

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation with a pentaray nav high-density mapping eco catheter and suffered a cerebrovascular accident.Transseptal puncture was performed.Soundmerge was conducted using the soundstar catheter.There was no evidence of a thrombus.At an unspecified point during ablation, the patient became unresponsive to verbal stimuli.Post-procedure, patient was unconscious.Magnetic resonance imaging (mri) confirmed a cerebral infarction.No interventions were reported.There is no information regarding extended hospitalization.Patient outcome is unchanged.Upon re-review of the pre-procedure echocardiogram, a haze-like shadow was detected, but no thrombus was confirmed.It was noted that the pentaray catheter entered the left atrial appendage (laa) multiple times during the creation of the left atrial voltage map.Although the physician did not provide a causality opinion, he did indicate that a thrombus may have been scraped out of the laa during left atrial voltage mapping with the pentaray catheter.Patient received direct-acting oral anticoagulant (doac) with activated clotting time (act) maintained in an unspecified range.It was noted that there were no pre-procedural or intra-procedural anticoagulation issues.

Manufacturer Narrative

Additional information was received 7/6/2018.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.In addition, the expiration date (2021/01/24) and manufacturing date (2018/01/25) were provided.The corresponding fields of this report have been updated.Manufacturer ref no: (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7653376
• MDR Text Key: 112843076
• Report Number: 2029046-2018-01754
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2021
• Device Catalogue Number: D128211
• Device Lot Number: 30013424L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening