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

Model Number	7010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient underwent percutaneous coronary intervention (pci) under local anesthesia.After implantation of coronary stent, a high-pressure balloon was planned, and a 2.5mm x 12mm quantum maverick balloon catheter was selected for use.However, after opening the package, it was noted that the shaft broke around the middle of delivery rod and could not be used normally.The physician replaced the balloon immediately to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that shaft break occurred.The patient underwent percutaneous coronary intervention (pci) under local anesthesia.After implantation of coronary stent, a high-pressure balloon was planned, and a 2.5mm x 12mm quantum maverick balloon catheter was selected for use.However, after opening the package, it was noted that the shaft broke around the middle of delivery rod and could not be used normally.The physician replaced the balloon immediately to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube at 69cm from the strain relief.The separated ends of the hypotube were ovaled in shape indicating the device was kinked prior to separation.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Product analysis confirmed the reported break as there was separation to the device.

• Brand Name: QUANTUM MAVERICK
• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15876661
• Report Number: 2124215-2022-49596
• Device Sequence Number: 5446304
• Product Code: LOX
• UDI-Device Identifier: 08714729392651
• UDI-Public: 08714729392651
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• 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): 01/11/2023

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: 06/16/2025
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0029608037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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