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 Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

Event Description

It was reported that catheter entrapment on guidewire occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75mm x 12mm nc emerge balloon catheter was advanced for dilation.However, upon removal, it came out with a wire.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.

Event Description

It was reported that catheter entrapment on guidewire occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75mm x 12mm nc emerge balloon catheter was advanced for dilation.However, upon removal, it came out with a wire.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.It was further reported that the wire was stuck with the catheter upon removal and the lesion was severely calcified.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.The device was bloody and filled with contrast.Analysis of the tip, balloon, inner/outer shaft and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube.Inspection of the rest of the device found no other damage or defects.The wire used with the device, in the procedure, was not available for device to device testing, so a lab supplied wire was used for testing.The test wire was inserted into the nc emerge tip and advanced through the shaft.The wire moved easily and without issue.The reported wire difficulty was not confirmed, although clinical circumstances could not be replicated.

Event Description

It was reported that catheter entrapment on guidewire occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75mm x 12mm nc emerge balloon catheter was advanced for dilation.However, upon removal, it came out with a wire.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.It was further reported that the wire was stuck with the catheter upon removal and the lesion was severely calcified.

• 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: 10884118
• MDR Text Key: 217647163
• Report Number: 2134265-2020-16094
• 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,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2022
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0025813192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR