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

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

Patient Problem Ischemia Stroke (4418)

Event Date 07/28/2022

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

During an ablation procedure a polarsheath was selected for use.The transseptal puncture was performed with a competitor transseptal sheath with no issues.The physician attempted to insert the guidewire (still inside the transseptal sheath) into the left superior pulmonary vein (lspv), however, he always ended up inserting it in the left atrial appendage.After multiple attempt, the transeptal sheath was exchanged for the polarsheath.It was still not possible to insert the guidewire into the lpsv.The polarsheath was exchanged for another competitor transeptal sheath, however, the issue persisted.The sheath was exchanged for the polarsheath and was finally able to reach into the lspv.The remainder of the procedure was completed successfully with no problems.With all four veins isolated.Post procedure the patient exhibited neurological symptoms on his right eye.The patient is expected to recover.Neurologist believe they are expected to fully recover.It is believed that the patient's symptoms are due to the multiple sheath exchanges.

• 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 DE COSTA RICA S.R.L.; 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: 15243187
• MDR Text Key: 298084855
• Report Number: 2134265-2022-08551
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other