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

• 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

• 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

Was the Report Sent to FDA?

• Event Location: No Information
• 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

Patient Treatment Data

Date Received: 09/06/2017 Patient Sequence Number: 1