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

Model Number	1865
Medical Device Problem Codes	Material Rupture (1546); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with coronary artery disease and was to undergo percutaneous coronary intervention.The 99% stenosed target lesion was located in the severely tortuous and severely calcified mid right coronary artery (rca).A 1.2mm x 12mm threader balloon catheter was advanced but failed to pass the lesion.However, during the second inflation at 12 atmospheres (atm), the balloon ruptured.The device was removed and another 1.2mm x 12mm threader balloon catheter was advanced, but it also failed to pass the lesion and during third inflation at 12 atm, the balloon ruptured.The device was removed and a 1.5x12 non-boston scientific balloon catheter was placed to treat the lesion.Subsequently, the physician proceeded to the moderately tortuous and severely calcified proximal rca with 95% stenosis.A 2.25mm x 12mm nc emerge balloon catheter was advanced for dilatation; however, during second inflation at 16 atm, the balloon ruptured.The device was removed, and due to the nature of the procedure, the patient will be returning for a rotablator procedure.No patient complications were reported.

• Brand Name: THREADER
• 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: 17653501
• Report Number: 2124215-2023-46152
• Device Sequence Number: 6331333
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: 08714729848134
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K134031
• 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): 08/30/2023

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: 07/14/2023
• Device Model Number: 1865
• Device Catalogue Number: 1865
• Device Lot Number: 0027661559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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: Male