MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 6530

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

Patient Problem Death (1802)

Event Date 10/31/2018

Event Type  Death  

Event Description

It was reported that patient died. Vascular access was obtained via the femoral artery. The 90% stenosed, 3. 5x20mm, eccentric and de novo target lesion was located in the moderately tortuous and non calcified left circumflex (lcx) artery. The lesion contained a bend between 45 and 90 degrees. Following pre-dilation, two non-bsc stent were implanted to treat the target lesion. Post-dilation was performed with two 2. 75x8mm nc quantum apex balloon catheters and a 3. 50x8mmnc quantum apex balloon catheter. The patent was shifted to coronary care unit and died. No autopsy was performed.

• Brand Name: NC QUANTUM APEX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8101628
• MDR Text Key: 128271543
• Report Number: 2134265-2018-63079
• 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,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/30/2021
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0022193512
• 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: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/26/2018 Patient Sequence Number: 1

Treatment

GUIDE CATHETER: MEDTRONIC; STENTS: ABBOTT