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

Model Number	6531
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel dissection occurred.Vascular access was obtained via the right femoral artery.The 80% stenosed, 36mm in length, concentric, de novo target lesion was located in the moderately tortuous, non-calcified, 3mm in diameter left anterior descending (lad) artery.After a 3.5 6f extra back-up (ebu) guide catheter engaged the lad and was co axially wired with a non-bsc guide wire, the lesion was pre-dilated with 2.5 x 9 maverick balloon catheter leaving 60% residual stenosis.A 38 x 3.00 promus premier drug-eluting stent was deployed; however, following post-dilatation with nc quantum apex balloon catheter, a stent edge dissection in proximal end was noted.The dissection part was then covered with another of the same device and the procedure was completed.No further patient complications were reported and the patient status was stable.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8267959
• Report Number: 2134265-2019-00192
• Device Sequence Number: 16736759
• Product Code: LOX
• UDI-Device Identifier: 08714729783268
• UDI-Public: 08714729783268
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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: 06/18/2021
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0022273568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2018
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BMW GUIDE WIRE; EBU 3.5 GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR