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 Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: the device was returned for analysis.There is a kink in the device approximately 17mm from the distal tip in the neutral position.The kink is between r2 and r3.The seals to r2 and r3 are compromised; there is body fluid along the edge of the rings.Electrical test was performed and the device was found within specifications.No opens or shorts were found.The ablation was verified by using the maestro generator 4000 and the device was found within specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Reportable based on device analysis completed on 19-april-2017.It was reported that electrogram interference occurred.A blazer prime¿ xp was selected for use.During the latter stage of the procedure, and following a number of ablations to the cavotricuspid isthmus (cti), an intermittent loss of the electrogram was noted,when the ablation distal electrogram became raised of the baseline shown on the recording system.This occurred intermittently without any noticeable change in the catheter position.The ablation proximal electrogram was unaffected.The procedure was completed with another of the same device.No patient complications reported and patient's status was stable.However, device analysis revealed that the r2 and r3 seals were compromised; there is body fluid along the edge of the rings.

• 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: 6551571
• MDR Text Key: 74647745
• Report Number: 2134265-2017-04397
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2018
• Device Model Number: M004EPTP4500THN40
• Device Catalogue Number: EPTP4500THN4
• Device Lot Number: 17879108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2015
• 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