MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX / DIALATION CATHETER; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493912415320
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon would not cross into stent, was removed.During removal, the device came apart (broke) into two separate pieces.Fda safety report id# (b)(4).

• Brand Name: NC QUANTUM APEX / DIALATION CATHETER
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 11655278
• Report Number: MW5100714
• Device Sequence Number: 11537670
• Product Code: LOX
• UDI-Device Identifier: 08714729783381
• UDI-Public: 08714729783381
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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: 03/12/2023
• Device Model Number: H7493912415320
• Device Catalogue Number: H7493912415320
• Device Lot Number: 26456498
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 91