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

Model Number	7213
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on additional information on 15-sept-2021.It was reported that catheter entrapment occurred.The 85% in-stent restenosis (isr) target lesion was located in the non-calcified and non-tortuous proximal saphenous vein graft to obtuse marginal.A 4.50mm x 15mm nc emerge balloon catheter was advanced for dilatation and was inflated twice at 26 atmospheres for 20 seconds.The device was fully deflated, however, it would not come out of the guide catheter.The physician then pulled everything out together and the procedure was completed successfully.No patient complications were reported.It was further reported that the balloon was also stuck on the wire.The physician had to remove the guide, balloon, and wire together.

• 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: 12576716
• Report Number: 2134265-2021-11922
• Device Sequence Number: 3322275
• Product Code: LOX
• UDI-Device Identifier: 08714729846574
• UDI-Public: 08714729846574
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/05/2021

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: 05/18/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0027332212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1