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

Model Number	7142
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in coronary artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilation.However, despite application of pressure, the balloon could not be inflated; and a visible pinhole was observed on the balloon material.The procedure was then completed with a different device.There were no patient complications reported, and the patient condition was stable post-procedure.
Additional Manufacturer Narrative
E1: initial reporter phone:(b)(6).
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in coronary artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilation.However, despite application of pressure, the balloon could not be inflated; and a visible pinhole was observed on the balloon material.The procedure was then completed with a different device.There were no patient complications reported, and the patient condition was stable post-procedure.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr.: returned product consisted of an emerge otw balloon catheter.Visual, microscope, and functional testing were performed on the device.Inspection revealed no damage or irregularity.There was contrast present within the inflation lumen, and the balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the calibrated pressure gage to inflate the device.The device inflated to rated burst pressure (14atm) and deflated with no issue.Product analysis could not confirm reported event as the device inflated to rated burst pressure and deflated with no issue.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18403356
• Report Number: 2124215-2023-73763
• Device Sequence Number: 11437736
• Product Code: LOX
• UDI-Device Identifier: 08714729806714
• UDI-Public: 08714729806714
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: 08/22/2024
• Device Model Number: 7142
• Device Catalogue Number: 7142
• Device Lot Number: 0030004724
• 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: 12/15/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 68 KG