MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARMAP; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004CRBSUSC7200

Device Problem Contamination (1120)

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

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

Patient weight: (b)(6).

Event Description

Frozen af clinical study.It was reported that during the replacement of a polarx balloon catheter during a paroxysmal atrial fibrillation cryo-ablation procedure, the polarmap catheter touched non-sterile area.The polarmap catheter was replaced.No patient complications were reported.

Event Description

Frozen af clinical study.It was reported that during the replacement of a polarx balloon catheter during a paroxysmal atrial fibrillation cryo-ablation procedure, the polarmap catheter touched non-sterile area.The polarmap catheter was replaced.No patient complications were reported.

Manufacturer Narrative

Patient weight: 59.2 kg.Visual inspection of the device showed no damage was identified on the polarmap.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: POLARMAP
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• MDR Report Key: 11922775
• MDR Text Key: 254330603
• Report Number: 2134265-2021-07132
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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 Expiration Date: 08/10/2021
• Device Model Number: M004CRBSUSC7200
• Device Lot Number: 0026098734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 07/13/2021
• Patient Sequence Number: 1
• Patient Age: 29 YR