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

Model Number M004EPT9620K20

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2015.It was reported that a shaft kink occurred.A 7.5x110x2.5 open irrigated quad lgr was selected to treat the target lesion.During the procedure, it was noted that irrigation hub tubing of the catheter is unusually flexible and kinks very easily when maneuvering the catheter.There were no patient were complications reported.However, device analysis revealed broken adhesive at ring# 3.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The device has a kink at 8.5cm from the tip while in the neutral position.In addition the ring 3 has broken adhesive and fluids under 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 as device performance was limited due to anatomical procedural factors.(b)(4).

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4948351
• MDR Text Key: 6254796
• Report Number: 2134265-2015-04719
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SIMILAR
• 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: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2017
• Device Model Number: M004EPT9620K20
• Device Catalogue Number: EPT9620K2
• Device Lot Number: 17257924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• 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