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

Model Number	M004P5031TH0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
It was reported that patient experienced tamponade.A blazer prime® htd was selected to be used.During the procedure, it was noted that the patient had a tamponade and pericardiocentesis had to be performed.No further patient complications reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that during supra ventricular tachycardia ablation procedure, no vessel perforation was noticed.The procedure was not completed.

• Brand Name: BLAZER PRIME® HTD
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6407768
• Report Number: 2134265-2017-02031
• Device Sequence Number: 797586
• Product Code: LPB
• UDI-Device Identifier: 08714729803614
• UDI-Public: (01)08714729803614(17)20190919(10)19737130.
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2019
• Device Model Number: M004P5031TH0
• Device Catalogue Number: P5031TH
• Device Lot Number: 19737130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR