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

Model Number M004P4500THK20

Device Problems Hole In Material (1293); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2014

Event Type  malfunction  

Event Description

It was reported that an internal component came out of the catheter.The target lesion was located in the heart.A 7-110-2.5-8-8 k2 blazer prime® xp was selected and advanced to treat the lesion.During the procedure, it was noted that the curved part of the device near the 3rd electrode was damaged.The device was removed successfully from the patient's body and it was observed that the inner part of the device was protruding from the catheter shaft.The procedure was completed with another of the same device.There were no reported patient complications and the patient status is good.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Manufacturer Narrative

Device evaluated by mfr: device was returned for analysis.The device is severely damaged at the distal section.The distal section is kinked at 1.7cm from the tip and is twist at 9cm from the tip, and the ring 2 is deformed and the adhesive is broken, there is blood residues inside the device, the center support is protruding out, ripping the distal section at 1.5cm from the tip.Also, there are chars in the rings 1 and 2.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).

Event Description

It was reported that an internal component came out of the catheter.The target lesion was located in the heart.A 7-110-2.5-8-8 k2 blazer primep was selected and advanced to treat the lesion.During the procedure, it was noted that the curved part of the device near the 3rd electrode was damaged.The device was removed successfully from the patient's body and it was observed that the inner part of the device was protruding from the catheter shaft.The procedure was completed with another of the same device.There were no reported patient complications and the patient status is good.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4184690
• MDR Text Key: 5160014
• Report Number: 2134265-2014-06298
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2015
• Device Model Number: M004P4500THK20
• Device Catalogue Number: P4500THK2
• Device Lot Number: 0015384075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2012
• 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