MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493912412300

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 08/17/2017

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr# 2134265-2017-08879, 2134265-2017-08878, and 2134265-2017-08942.It was reported that hypotension, bradycardia, cardiac arrest and death occurred.Vascular access was obtained via the femoral artery.The 95% stenosed, 18mm x 3mm, concentric, denovo, target lesion was located in a non tortuous, severely calcified mid left anterior descending artery (lad).Following rotablation with a 1.50mm rotalink¿ plus there was slow flow.Medication was administered and timi-3 restored.The lesion was successfully stented with a 3.00x28mm promus element¿ plus.A 12x3.00mm nc quantum apex¿ balloon catheter and a 2.00x12mm maverick²¿ balloon catheter were used during the procedure.The patient was moved to the intensive care unit and while there developed hypotension followed by bradycardia.The patient went into cardiac arrest and died.

• Brand Name: NC QUANTUM APEX¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6845621
• MDR Text Key: 85004582
• Report Number: 2134265-2017-08948
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K121667
• 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: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: H7493912412300
• Device Catalogue Number: 39124-1230
• Device Lot Number: 19452922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR