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

Model Number 6533

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Event date: used (b)(6) 2018 as there was event date provided.

Event Description

It was reported via voluntary medwatch that balloon perforation occurred.The target lesion was located in the right coronary artery.A 2.5x20mm nc quantum apex balloon catheter was advanced for dilatation.However, when the device was advanced over the wire, the wire did not exit in the proper place, instead it exited through the balloon.No patient complications were reported and the patient was not harmed.

• 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: 8115625
• MDR Text Key: 128769199
• Report Number: 2134265-2018-63254
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729783466
• UDI-Public: 08714729783466
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2020
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0021225573
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2017
• 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