MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS TRANSLUMNIAL CORONARY ANGIOPLASTY PERCUTANEOUS

Model Number 7216

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Used the first day of the month of the aware date as event date since no date was provided.

Event Description

It was reported that balloon markerbands were missing.A 3.50mm x 6mm nc emerge was used in a procedure.However, it was noted that the markerbands on the balloon were missing.No patient complications were reported and the patient status was stable.

• Brand Name: NC EMERGE
• Type of Device: CATHETERS TRANSLUMNIAL CORONARY ANGIOPLASTY PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9481837
• MDR Text Key: 176483431
• Report Number: 2134265-2019-15788
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729857877
• UDI-Public: 08714729857877
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: 7216
• Device Catalogue Number: 7216
• Device Lot Number: 0023504694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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