MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) AMPLATZ SUPER STIFF¿; WIRE, GUIDE, CATHETER

Model Number UNK852

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Internal Organ Perforation (1987)

Event Date 06/16/2016

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that ventricle perforation and death occurred.Transcatheter aortic valve implantation (tavi) was performed using a 26mm diameter non-bsc valve.An amplatz wire was used.When the valve was deployed for about 1/3, the blood pressure of the patient decreased and left ventricular perforation was observed through echo.While preparing the pcps (percutaneous cardiopulmonary assist device), the patient was observed to have cardiac arrest.Then, pcps was connected and surgical procedure was performed.At that time, the valve was implanted.Since the heart torn over a wide range, artificial heart-lung device was used and suturing was performed using pericardial patch.After closing the wound, decannulation was not performed and the procedure was completed with the pcps being attached as it was.On the same day, the patient died due to circulatory failure.The physician considered that one of the causes of the left ventricular perforation was that the guidewire was pushed more than the expected.

• Brand Name: AMPLATZ SUPER STIFF¿
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7176533
• MDR Text Key: 96781333
• Report Number: 2134265-2017-12858
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K843012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK852
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Death; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 41