• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH Back to Search Results
Model Number M004CRBS3050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982); Paralysis (1997)
Event Date 11/13/2020
Event Type  Injury  
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event Description
It was reported that a pulmonary vein isolation (pvi) cryoablation procedure for the treatment of atrial fibrillation was successfully completed with a polarx balloon catheter, a polarsheath steerable sheath and a polarmap catheter 20mm. The patient's activated clotting time (act) was >300 seconds at all times during the procedure. The blood coagulation was in the targeted area due to the administration of heparin. The patient was also undergoing oral anticoagulation with pradaxa 110mg 1-0-1. The last dose was given on the morning of the procedure. While the balloon catheter was being prepared, an alert was displayed on the console indicating the outer balloon pressure was too high when the cryo cable was connected to the catheter and console. As a result, the cryo cable was replaced and no other alerts were noted. This exchange took place before the catheter was inserted into the patient's body and had no impact on the patient. During the procedure, the sheath and the balloon catheter were constantly flushed without any issues or interruptions. There were no complications observed and therefore all products were disposed after use. There was no evidence of an embolic event or st elevation during the examination. Approximately 2-3 hours after the procedure, the patient suffered from a neurological event. He had minor problems with paralysis on his left arm (weak left arm dorsiflexion) and ataxia. The neurological examination suggested a stroke. An immediate computerized tomography (ct) scan revealed no evidence of ischemia or bleeding (no findings). As the disease progressed, the symptoms decreased again. The next day, the patient again had problems with paralysis as well as trouble talking. The patient complained of tingling paresthesia in the left leg, a recurrence of the weak arm lifting on the left and difficulty finding words. The patient was transferred to the neurology department and another ct scan of the head was performed without any findings. There was no evidence of ischemia or cerebral hemorrhage. The following day, the issues again had resolved almost completely. The symptoms improved again spontaneously, and since then the patient has been completely symptom-free again without neurological deficits. When the physician went to see the patient, apart from some difficulties in his left arm, the ataxia had resolved. A magnetic resonance imaging (mri) was performed and showed "acute to subacute microinfarcts in the right lobus parietalis superior; slight microangiopathic leukoencephalopathy. " a stroke diagnosis was confirmed. The cause of the event was not determined. The adverse event appeared to be related to the procedure, and there was no evidence of product involvement. The patient made a full recovery and was released from the hospital. The patient is expected to fully recover.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOLARSHEATH
Manufacturer (Section D)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway
global park, la aurora
heredia
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key11003947
MDR Text Key221477902
Report Number2134265-2020-17649
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/13/2021
Device Model NumberM004CRBS3050
Device Lot Number0025554636
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/14/2020 Patient Sequence Number: 1
Treatment
POLARMAP CATHETER 20MM; POLARX BALLOON CATHETER
-
-