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	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported shaft break occurred.A 3.0mm x 12mm quantum maverick balloon catheter was selected for use; however, during preparation, it was noted that the device fractured.The procedure was 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 incomplete quantum maverick balloon catheter.Photo media is attached to the complaint record.Visual inspection revealed that at 44.5cm proximal from the midshaft bond, the hypotube was separated.There were numerous hypotube and shaft kinks to the device.Total device returned length was 80.3cm which failed to include the proximal end of the hypotube, strain relief, and the hub.No further damage or irregularity observed on the device.There was blood and contrast in the inflation lumen, blood in the guidewire lumen, and the balloon was tightly folded.Media reviewed depicted a hypotube separation to the complaint device as well as the devices outer box packaging confirming the reported events.Product analysis confirmed the reported break as there was separation to the device.
Event or Problem Description
It was reported shaft break occurred.A 3.0mm x 12mm quantum maverick balloon catheter was selected for use; however, during preparation, it was noted that the device fractured.The procedure was completed with a different device.There were no patient complications reported, and the patient condition was stable post-procedure.

• Brand Name: QUANTUM MAVERICK
• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18423243
• Report Number: 2124215-2023-74288
• Device Sequence Number: 8173845
• Product Code: LOX
• UDI-Device Identifier: 08714729392675
• UDI-Public: 08714729392675
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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: 03/10/2025
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0029025295
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 01/01/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 68 KG