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 Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Unspecified Heart Problem (4454)

Event Date 02/02/2021

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 during a pulmonary vein isolation (pvi), a "medical incident" occurred.During the preparation of the polarx balloon catheter, the patient suffered a cardiac decompensation as a result of which their blood pressure and oxygen saturation fell.Only the polarsheath was introduced over the groin and placed in the left atrium at the time.The event prevented the procedure from being completed.According to the physicians, the patient was doing better afterwards.More detailed information was not available.No more air could be detected by a cardiovascular computed tomography (cct) and the electrocardiogram (ekg) changes that were noticed during the emergency management were all reversible.The upns and lot numbers were not known.According to the physicians, no major product defects could be identified before the intervention.Neither a leak at the sheath, nor an observed air embolism could be observed.The dilator had been moistened and no other catheters had been inserted into the sheath.The products were discarded after the procedure and therefore will not be returned for analysis.

• 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: 11327899
• MDR Text Key: 231939491
• Report Number: 2134265-2021-01777
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M004CRBS3050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other