MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER PRIME¿ XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004EPTP4500THN40

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the returned device showed body fluid on the handle and the distal tip.A slight kink was evident near ring 3.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Tip motion was evaluated against the specified curve template.Both right and left curves failed to reach the specified template area.During the right curve test, a kink was verified between rings 2 and 3.X-ray found a severe bend in the center support at distal edge of ring 3.The distal section was dissected.The kevlar wrap was displaced and a bent center support was protruding through the kevlar wrap between rings 2 and 3.Dried body fluid was found on the kevlar wrap surrounding the area of the protrusion.This body fluid most likely entered the main body tubing interior under the distal edge of ring 3 and then through the ring 3 wire hole.The initial visual inspection did not find body fluid specifically in the ring 3 area.The kevlar wrap was dissected from the area surrounding the protrusion.Once the wrap was removed, the center support was found broken.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2017.It was reported that catheter curve issues occurred and was kinked.A blazer prime xp was selected for use.During the procedure, it was noted that the curve of the catheter was no longer usable and it appeared to be kinked.The procedure was completed with another of the same device.No patent complications were reported.However, device analysis revealed died body fluid in the interior of the device.

• Brand Name: BLAZER PRIME¿ XP
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 7195953
• MDR Text Key: 97771738
• Report Number: 2134265-2017-13139
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2020
• Device Model Number: M004EPTP4500THN40
• Device Catalogue Number: EPTP4500THN4
• Device Lot Number: 20848197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• 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