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

Model Number 7164

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

The returned product consisted of an emerge balloon catheter.Microscopic and visual examination of the device identified numerous hypotube kinks.There was contrast in the inflation lumen and balloon, and blood within the guidewire lumen, consistent with use.The balloon was loosely folded.There was no damage observed with the hub, which would indicate a possible connection problem.The emerge balloon catheter was successfully connected to an inflation device, filled with water and connected to the inflation port to inflate the device.There was a pinhole noted 6mm distal to the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 05feb2021.It was reported that device to device incompatibility occurred during a percutaneous coronary intervention on a patient with coronary artery disease.While attempting to inflate a 3.50mm x 20mm emerge balloon, the balloon disconnected from the luer.The connection was maintained by hand while another balloon (same model) was attached and the procedure was successfully completed.No patient complications were reported in relation to this event.However, device analysis identified a 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: 11361294
• MDR Text Key: 233049147
• Report Number: 2134265-2021-02142
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2023
• Device Model Number: 7164
• Device Catalogue Number: 7164
• Device Lot Number: 0026000560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1