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

Model Number	7130
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2134265-2021-15697
• Device Sequence Number: 12189235
• Product Code: LOX
• UDI-Device Identifier: 08714729806523
• UDI-Public: 08714729806523
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown