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

Model Number	7143
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.A 2.50mm x 15mm emerge balloon catheter was selected for used.However, during the preparation the balloon was noticed had a hole.The procedure was completed with another balloon device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon pinhole occurred.A 2.50mm x 15mm emerge balloon catheter was selected for used.However, during the preparation the balloon was noticed had a hole.The procedure was completed with another balloon device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge otw balloon catheter.The device was visually and microscopically examined.At 22.6cm from the strain relief, the shaft was kinked.There was contrast present in the inflation lumen and balloon.There was blood in the guidewire lumen and the balloon.The balloon was loosely folded.The device was prepped with an inflation device and filled with water to test the device for inflation to rated burst pressure.The device failed to inflate to rated burst pressure.There was a 3mm longitudinal tear in the guidewire lumen 21.5cm from the tip of the device.Product analysis confirmed the reported event, as the guidewire lumen had a longitudinal tear.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16401942
• Report Number: 2124215-2023-07514
• Device Sequence Number: 5706116
• Product Code: LOX
• UDI-Device Identifier: 08714729806820
• UDI-Public: 08714729806820
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: 04/07/2024
• Device Model Number: 7143
• Device Catalogue Number: 7143
• Device Lot Number: 0029193091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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