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	06/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that product was mislabeled.A 3.75mm x 15mm nc emerge balloon catheter was requested for use in a coronary treatment procedure.The scrub technician selected an emerge balloon catheter from a box labeled 3.75mm x 15mm nc emerge balloon catheter.The emerge balloon catheter was prepared and advanced to the lesion.Under fluoroscopy, the balloon size did not look accurate.The emerge balloon catheter was removed from the patient.Upon inspection it was observed on the manifold that the emerge was a 2.5mm x 12mm and not 3.75mm x 15mm as labeled.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of packaging to an nc emerge balloon catheter, outer box, product pouch, and protective hoop.The device returned was an emerge balloon catheter.The product pouch was visually inspected.The product pouch contained a unit for batch 25904100.The batch number on the returned packaging was 25911565.The tyvek seal was inspected, and it was pulled open on the back flap of the packaging.The batches to these devices were run simultaneously and at the same packaging station.The device was microscopically and visually examined.There was contrast present in the inflation lumen and the balloon folds.The balloon was tightly folded.Inspection of the remainder of the packaging and device presented no other damage or irregularities.Product analysis found the device was not compatible with the packaging returned.
Event or Problem Description
It was reported that product was mislabeled.A 3.75mm x 15mm nc emerge balloon catheter was requested for use in a coronary treatment procedure.The scrub technician selected an emerge balloon catheter from a box labeled 3.75mm x 15mm nc emerge balloon catheter.The emerge balloon catheter was prepared and advanced to the lesion.Under fluoroscopy, the balloon size did not look accurate.The emerge balloon catheter was removed from the patient.Upon inspection it was observed on the manifold that the emerge was a 2.5mm x 12mm and not 3.75mm x 15mm as labeled.The procedure was completed with a different device.No patient complications were reported.

• 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: 12213166
• Report Number: 2134265-2021-09428
• Device Sequence Number: 3210229
• Product Code: LOX
• UDI-Device Identifier: 08714729846550
• UDI-Public: 08714729846550
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Followup
• Report Date (Section B): 09/01/2021

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: 08/25/2022
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0025911565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1