MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER¿ II HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M004EPT5031THN40

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that catheter damage occurred.During unpacking, a blazer¿ ii htd catheter was noted to have a crack near the tip.The procedure was completed by opening a new catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: visual inspection revealed a circumferential cut in the shaft approximately at 9 cm from the distal tip while in the neutral position was noted.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).

Event Description

It was reported that catheter damage occurred.During unpacking, a blazer ii htd catheter was noted to have a crack near the tip.The procedure was completed by opening a new catheter.No patient complications were reported.

• Brand Name: BLAZER¿ II HTD
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7454649
• MDR Text Key: 106298994
• Report Number: 2134265-2018-03419
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: P920047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2020
• Device Model Number: M004EPT5031THN40
• Device Catalogue Number: EPT5031THN4
• Device Lot Number: 21309479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• 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