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

Model Number 7312

Device Problem Entrapment of Device (1212)

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

Event Date 05/11/2021

Event Type  malfunction  

Event Description

It was reported that catheter entrapment on guidewire occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, after deflation, the balloon catheter was tried to move but the guidewire moved together with the balloon.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.

Event Description

It was reported that catheter entrapment on guidewire occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, after deflation, the balloon catheter was tried to move but the guidewire moved together with the balloon.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.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 guidewire used in the procedure was not returned for analysis, so a test 0.014 guidewire was used for functional testing.The guidewire failed to pass through the distal portion of the device as there was resistance near the proximal markerband.The guidewire was inserted through both the exit notch and the tip of the device and encountered difficulties on both sides of the proximal markerband.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.This functional test was used as a visual aid to help identify the resistance found during wire insertion.The markerband presented no issue.The guidewire lumen was stretched down and due to the slightness inflation was used to determining factor.The damage starts approximately nearest to the proximal waist of the balloon and does not exceed the distal markerband.

• 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: 11932403
• MDR Text Key: 254318816
• Report Number: 2134265-2021-06736
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0026783883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR