MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARMAP; CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE

Lot Number 0031941166

Device Problem Material Perforation (2205)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(6) 2023 during preparation of an atrial fibrillation procedure a polarmap catheter was selected for use.It was noted that "metal cover" was broken, further clarification on the damage was requested however no information was available.No patient complications occurred as the issue occurred prior to introduction into the patient.The procedure was completed without any patient complications.However, analysis of the returned device revealed a fracture of the nitinol hypo-tube shaft and the inner wires were exposed.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was visually inspected which revealed the polarmap body has a break near the proximal end.The reported allegation of the catheter break was confirmed.The most likely cause was determined to be that an unintended use error caused or contributed to event as the damage occurred while trying to prepare the catheter.

• Brand Name: POLARMAP
• Type of Device: CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE
• 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: 18277151
• MDR Text Key: 329857491
• Report Number: 2124215-2023-69226
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0031941166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1