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

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.

• Brand Name: POLARSHEATH
• 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 Key: 11003947
• MDR Text Key: 221477902
• Report Number: 2134265-2020-17649
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025554636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: POLARMAP CATHETER 20MM; POLARX BALLOON CATHETER
• Patient Outcome(s): Hospitalization; Other