BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
|
Back to Search Results |
|
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).
|
|
Search Alerts/Recalls
|
|
|