MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE BLAZER¿ OPEN-IRRIGATED; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M004EPT9620K20

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The device has no visible defects.Upon using the keyence/microscope there is visible evidence of 5 out of 6 of the irrigation ports are blocked from foreign material.There is blood in the tip which could cause the holes block.The ablation testing could not be verified by using the maestro generator 4000 and metriq pump, and the device was not found within specifications.Electrical test could not be conducted because of high impedance occurring from a block occlusions in the irrigation ports at the distal tip.No opens or shorts were found.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

Reportable based on device analysis completed on 02-mar-2017.It was reported that noise was noted over the distal electrodes.A 7.5 110 2.5 blazer¿ open-irrigated was selected for use.During the procedure, when the catheter was inside the patient and after pacing the high right atrium, a baseline wonder type noise was noted over the distal electrodes.The bipol 1-2 pins were changed in the junction box and a new cable was tried but the problem persisted.The catheter was then removed and replaced with another of the same device and then only a mild noise was noted.No patient complications were reported and the patient's status was stable.However, device analysis revealed that 5 out of 6 of the irrigation ports were blocked with dried blood.

• Brand Name: BLAZER¿ OPEN-IRRIGATED
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6427003
• MDR Text Key: 70640358
• Report Number: 2134265-2017-02918
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P150005
• 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: 03/02/2017

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: 03/31/2018
• Device Model Number: M004EPT9620K20
• Device Catalogue Number: EPT9620K2
• Device Lot Number: 17790037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• 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
• Patient Age: 70 YR