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

Model Number 7213

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

Event Description

It was reported that catheter entrapment occurred. The target lesion was fibrotic plaque within the left anterior descending artery. A 4. 00mm x 15mm nc emerge balloon catheter was advanced for post dilation. However, the balloon got stuck onto the wire and was not able to be removed without pulling out both devices together. After that, a new 4. 00mm x 8mm nc emerge balloon catheter and a non-bsc guidewire was placed, but after one inflation both devices got stuck also. And so both devices were removed. The procedure was completed with a placement of a new non-bsc wire into the vessel and ivus confirmed that the stent was well apposed. No patient complications were reported and the patient was stable.

• 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: 9733566
• MDR Text Key: 180613077
• Report Number: 2134265-2020-01774
• Device Sequence Number: 1
• Product Code: LOX
• 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

• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/19/2021
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0024962375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial