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

Model Number 7133

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an emerge balloon catheter. The shaft, hypotube, tip and balloon were microscopically and visually examined. There were numerous kinks. There was contrast and blood in the inflation lumen and balloon. The balloon was loosely folded. Microscopic inspection revealed tip damage. There was a pinhole at the proximal marker band. There was no marker band damage detected. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis confirmed the reported kink.

Event Description

Reportable based on device analysis completed on 14-jan-2021. It was reported that shaft kink occurred. The 95% stenosed target lesion was located in the distal left anterior descending artery. A 2. 00mm x 15mm emerge balloon catheter was advanced for dilatation; however, the delivery shaft got kinked. The procedure was completed with another of same device. There were no patient complications reported and the patient's status was stable. However, returned device analysis revealed balloon pinhole.

• Brand Name: 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11206856
• MDR Text Key: 227965855
• Report Number: 2134265-2021-00510
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/20/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0024924831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial