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

Lot Number 0031147376

Device Problem Material Perforation (2205)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during preparation for a cryo-ablation procedure using a polarmap catheter the shaft of the catheter broke near the attachment sleeve.There were no patient complications.No information regarding troubleshooting or the outcome of the procedure were provided.The catheter is expected to be returned for analysis.

Event Description

It was reported that during preparation for a cryo-ablation procedure using a polarmap catheter the shaft of the catheter broke near the attachment sleeve.There were no patient complications.They exchanged the catheter and the procedure was completed with no patient complications.The catheter is expected to be returned for analysis.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was visually inspected which revealed that the shaft of the catheter was fractured.The reported allegation of fracture was confirmed, and the root cause for the damage was determined to be due to an unintended use error caused or contributed to event as the damage occurred during preparation of the device.

• 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: 17481827
• MDR Text Key: 320633763
• Report Number: 2124215-2023-41361
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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 Expiration Date: 02/29/2024
• Device Lot Number: 0031147376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male