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

Model Number 7130

Device Problem Leak/Splash (1354)

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

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

Returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There were numerous hypotube kinks.There was contrast in the inflation lumen and balloon.There was blood in the guidewire lumen and the balloon was loosely folded.The device was soaked for a period of time to break up the contrast and blood in the device.The device was then prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole 6mm from the tip of the device.The device failed to inflate to rated burst pressure.

Event Description

Reportable based on device analysis completed on 07dec2021.It was reported that balloon leak occurred.A 2.50mm x 8mm emerge balloon catheter was advanced for dilatation.However, during first inflation the device failed to inflate.When the device was removed and inflated, a leaked was notice.The procedure was completed with another of same device.No patient complications were reported.However, device analysis revealed 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: 12994057
• MDR Text Key: 282558540
• Report Number: 2134265-2021-15697
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806523
• UDI-Public: 08714729806523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2024
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0027669183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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