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

Model Number 7313

Device Problem Entrapment of Device (1212)

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

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that froze on wire occurred.Chronic total occlusion located in mildly tortuous and moderately calcified vessel.Two 3.00mm x 15mm and 2.00mm x 15mm nc emerge balloon catheter were advanced for dilatation.However, during withdrawal, the balloon did not went out smoothly over the wire due to the frictions in the monorail and the wire was trapped and pulled back.While retracting the wire it was removed accidently.The devices were removed from the patients body and the procedure was completed with another of ame device.There were no patient complications reported.

Manufacturer Narrative

E1 initial reporter facility name: (b)(6).Device returned to manufacturer: this nc emerge balloon catheter and another manufacturers 0.014 guidewire were returned.The device was microscopically and visually examined.There was contrast in the inflation lumen and balloon.There was blood in the guidewire lumen.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device to loosen the blood and contrast in the device.The guidewire used in the procedure was returned for analysis and functional testing.The guidewire passed through device with no resistance or issues.The guidewire was inserted through both ends of the device and encountered no difficulties.

Event Description

It was reported that froze on wire occurred.Chronic total occlusion located in mildly tortuous and moderately calcified vessel.Two 3.00mm x 15mm and 2.00mm x 15mm nc emerge balloon catheter were advanced for dilatation.However, during withdrawal, while retracting the wire it was removed accidentaly due to the frictions of balloons.The devices were removed from the patients body and the procedure was completed with another of ame device.There were no patient complications reported.

• 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
• MDR Report Key: 11388317
• MDR Text Key: 234010594
• Report Number: 2134265-2021-02517
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

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: 01/14/2023
• Device Model Number: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 0026632983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1