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

Model Number M0044500THK20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: during device analysis, it was revealed that the device has broken adhesive and fluids under rings #1 and #3.In addition, the distal section is permanently curved and it had the shaft bumped close to each ring.Functional inspection revealed that the steering knob and the tension control knob functioned properly on both lock and unlock positions.Dimensional inspection both curves are not placed in the template shaded area, the device failed the dimensional test.X ray analysis revealed that the center support is kinked.The handle was opened, and a gap was found in one steering wire terminal, however, when the distal was dissected it was release and return to the normal position.The guide coild was inspected finding no issues on it.The distal section was dissected finding the center support kinked and permanent curved.The ferrule was inspected finding no issues on it.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context.(b)(4).

Event Description

Reportable based on device analysis completed on 30nov2015.It was reported that the steering tip of the catheter was broken.Two 7-110-2.5-8-8 k2 blazer prime tip was selected to treat the right ventricle.The curving mechanism or the distal curve broke on both catheters while working inside the patient's body.The broken tips were successfully taken out but the procedure was completed with the second device.No patient complications reported and patient's condition is good.However, returned device analysis revealed that ring #1, #2 & #3 have broken adhesive and fluids under them.

• Brand Name: BLAZER® II 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5305630
• MDR Text Key: 33722302
• Report Number: 2134265-2015-08736
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2018
• Device Model Number: M0044500THK20
• Device Catalogue Number: 4500THK2
• Device Lot Number: 18066750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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