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

Model Number	7133
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a labeling issue occurred.During preparation and while outside the patient, a box labelled as a 3.00mm x 15mm emerge had a 3.00mm x 15mm nc emerge device within the pouch.The procedure was completed successfully, and no patient complications resulted in relation to this event.
Event or Problem Description
It was reported that a labeling issue occurred.During preparation and while outside the patient, a box labelled as a 3.00mm x 15mm emerge had a 3.00mm x 15mm nc emerge device within the pouch.The procedure was completed successfully, and no patient complications resulted in relation to this event.This is the same event reported in 2134265-2022-05614.
Additional Manufacturer Narrative
B5 describe event or problem and h6 device codes: corrected.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14428934
• Report Number: 2134265-2022-05613
• Device Sequence Number: 12163702
• Product Code: LOX
• UDI-Device Identifier: 08714729806233
• UDI-Public: 08714729806233
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0026167478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown