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

Model Number 7210

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2018

Event Type  malfunction  

Event Description

It was reported that there was a labeling issue.It was noted during preparation to post dilate that the 4.00mm x 6.00mm nc emerge balloon was opened and the tag on the hub of the device said it was a 3.00mm x 8.00mm.The balloon was not used and never entered the patient as the issue was found during unpacking.

• Brand Name: NC EMERGE
• 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: 7866412
• MDR Text Key: 119931463
• Report Number: 2134265-2018-60886
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846192
• UDI-Public: 08714729846192
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2019
• Device Model Number: 7210
• Device Catalogue Number: 7210
• Device Lot Number: 0020754077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1