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

Model Number 7213

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Event 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
• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12576716
• MDR Text Key: 274745950
• Report Number: 2134265-2021-11922
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846574
• UDI-Public: 08714729846574
• 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: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1