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

Model Number	7213
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned to manufacturer: the packaging, shaft, hypotube, tip and balloon were microscopically and visually examined.The device was received in a carton for batch 26757951.There was no pouch in the carton.The device was from batch 26757951.The device inspection found there were numerous kinks.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported mislabeling as there was no pouch returned with the device.
Event or Problem Description
It was reported that a device had an incorrect label.A physician had requested a 3.5 x 15mm nc emerge balloon catheter.The sealed box was labelled as 3.5 x 15mm.The sealed inner pouch was labelled 4 x 8mm.The actual balloon was a 3.5 x 15mm despite the labelling on the inner pouch.The device was used for the procedure, which was completed successfully with no patient injury.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11613847
• Report Number: 2134265-2021-04297
• Device Sequence Number: 3159834
• Product Code: LOX
• UDI-Device Identifier: 08714729846543
• UDI-Public: 08714729846543
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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: 02/05/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0026757951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/05/2021
• Patient Sequence Number: 1