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

Model Number	7005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The patient was undergoing percutaneous coronary intervention.The 60% stenosed target lesion was located in the right lower limb.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, the balloon rod was found to be fractured.The patient was stable post procedure.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older e1: initial reporter facility name: (b)(6) e1: initial reporter phone:(b)(6) device evaluated by mfr.: fg quantum maverick, mr 3.5mm x 8mm delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the hypotube shaft identified a break at 44cm distal to the distal end of the strain relief.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.A microscopic examination of the balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of damage.
Event or Problem Description
It was reported that shaft break occurred.The patient was undergoing percutaneous coronary intervention.The 60% stenosed target lesion was located in the right lower limb.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, the balloon rod was found to be fractured.The patient 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: 20163413
• Report Number: 2124215-2024-54997
• Device Sequence Number: 7291798
• Product Code: LOX
• UDI-Device Identifier: 08714729392583
• UDI-Public: 08714729392583
• 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): 10/21/2024

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 Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0032777826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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