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

Model Number 7311

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter with a 0.014" guidewire stuck in the guidewire lumen.Visual examination revealed a kink on the hypotube 85.5cm from the hub, the hypotube is twisted, buckling in the guidewire lumen 30mm and 37mm from the tip.There is contrast present in the inflation lumen and balloon and the balloon is loosely folded.The guidewire was attempted to be removed but was unsuccessful.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that catheter entrapment occurred.A 75mm x 8mm nc emerge balloon catheter was advanced for dilation and inflated to about 20 atmospheres.When the physician went to remove the emerge the non bsc guidewire was also removed.The inflation was enough to complete the procedure and no patient complications were noted.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8343308
• MDR Text Key: 136259968
• Report Number: 2134265-2019-01175
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2020
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 0022244336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2018
• 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