MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER® II; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	M0045031T0
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that a difficulty in catheter removal occurred.The target lesion was located at the atrium.A 110x2.5 blazer® ii was selected for use.During the procedure, it was noted that the catheter was unable to insert inside the coronary sinus (cs).It was also observed that in the course of removing the device, a difficulty in removal was encountered.The procedure was completed with a different device.No patient complications were noted.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device does not have visual defects.There is a sticky substance on the proximal shaft between approximately 47 and 51cm from the distal end.The catheter tip was immersed in a 35.6c saline bath for approximately 2.5 hours.A 7f sheath was flushed with the saline and the catheter distal tip was inserted into the sheath without difficulty.The catheter was removed and reinserted again for a total of ten times.No issue was found with inserting or withdrawing the catheter from the 7fr sheath.The catheter also passed through a calibrated 7fr gauge block without difficulty.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Tip motion was evaluated against the specified curve template/fixture.Both right and left curve tests passed.A device history record (dhr) review was performed and no deviation was found.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 or Problem Description
It was reported that a difficulty in catheter removal occurred.The target lesion was located at the atrium.A 110x2.5 blazer ii was selected for use.During the procedure, it was noted that the catheter was unable to insert inside the coronary sinus (cs).It was also observed that in the course of removing the device, a difficulty in removal was encountered.The procedure was completed with a different device.No patient complications were noted.

• Brand Name: BLAZER® II
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6809619
• Report Number: 2134265-2017-08104
• Device Sequence Number: 2066527
• Product Code: LPB
• UDI-Device Identifier: 08714729082811
• UDI-Public: (01)08714729082811(17)20191123(10)0020000328
• Combination Product (Y/N): N
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2019
• Device Model Number: M0045031T0
• Device Catalogue Number: 5031T
• Device Lot Number: 0020000328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR: (B)(4).