MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493926712300

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Device evaluated by mfr. : it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).

Event Description

It was reported that balloon rupture and balloon detachment occurred. The 90% stenosed target lesion was located in the semi tortuous and highly calcified second diagonal branch of the left anterior descending artery (lad). A 2. 5x12mm nc emerge® balloon catheter was advanced for dilatation. However, the balloon was not able to get adequate plaque compression even at full inflation. The device was replaced with a 3. 00mm x 12mm nc emerge® balloon catheter. During inflation at 10 atmospheres, the balloon ruptured and was snagged in the plaque and blood was noted in the indeflator. Multiple techniques with different wires were used to remove the device and when the device was removed, it was noted that the delivery system become stretched, and the balloon itself got detached and remained in the artery. What remained of the delivery system was removed. It was apparent under fluoroscopy that there were radiopaque marker bands remaining inside the patient. The patient was then sent for coronary artery bypass graft and the remaining balloon catheter was removed. No further patient complications were reported and the patient's status was stable.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7341814
• MDR Text Key: 102599674
• Report Number: 2134265-2018-01823
• 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
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: H7493926712300
• Device Catalogue Number: 39267-1230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/15/2018 Patient Sequence Number: 1