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

Model Number M004EPTP4770THK20

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(6) 2014.Same case as mdr id #2134265-2014-05029.It was reported that during an ablation treatment procedure a blazer prime¿ xp catheter tip kinked and was difficult to manipulate or curve.The blazer prime¿ xp was replaced and the procedure was successfully completed without patient complications.However, returned device analysis revealed lifting glue in the electrodes.

Manufacturer Narrative

Device evaluated by manufacturer: a visual inspection was performed and the device has a kink at the distal section while it is in a neutral position at 1.5cm from the tip.In addition, the device has broken adhesive at the ring 2 and has blood evidence under the adhesive of the ring 2, and the rings damaged location match with kink location.The steering knob and the tension control knob functioned properly on both lock and unlock positions.Dimensional inspection was performed and the device failed the right and left curve.The device was dissected at the distal section and one steering wire and the center support are broken, at 1.7cm from the tip.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4037069
• MDR Text Key: 4802580
• Report Number: 2134265-2014-05030
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020025
• 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: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2016
• Device Model Number: M004EPTP4770THK20
• Device Catalogue Number: EPTP4770THK2
• Device Lot Number: 16487335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2013
• 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