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

Model Number	6532
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a catheter shaft break occurred.A 15mm x 3.00mm nc quantum apex was used during a percutaneous coronary intervention procedure.It was noted that the catheter of the nc quantum apex broke without any stress or pressure to the shaft.No patient harm resulted in relation to this event.
Event or Problem Description
It was reported a catheter shaft break occurred.A 15mm x 3.00mm nc quantum apex was used during a percutaneous coronary intervention procedure.It was noted that the catheter of the nc quantum apex broke without any stress or pressure to the shaft.No patient harm resulted in relation to this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 71.9cm from the strain relief.The separated ends of the hypotube were ovaled in shape indicating the device was kinked prior to separation.There were numerous kinks to the hypotube of the device.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded and had blood and contrast present within the folds.

• Brand Name: NC QUANTUM APEX
• 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: 13098723
• Report Number: 2134265-2021-16253
• Device Sequence Number: 4054225
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: 08714729783374
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: 10/21/2024
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0028250319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown