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

Model Number	7010
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).A2: age at time of event: 18 years or older.Device evaluated by mfr.: fg quantum maverick, mr 3.5mm x 12mm was returned to the complaint investigation site (cis).A visual and tactile examination revealed no issues with the hypotube shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.A detailed microscopic examination of the balloon material identified a pinhole in the balloon above the distal markerband.Microscopic examination of the proximal and distal markerbands identified no damage.Bumper tip showed signs of distal tip damage.The device was inflated to the rated burst pressure of 14 atmospheres and a pinhole was observed.
Event or Problem Description
Reportable based on device analysis completed on 05-nov-2024.It was reported that crossing difficulties occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 3.5mm x 12mm quantum maverick balloon catheter was advanced for dilation but failed to cross the lesion.The procedure was completed with another of the same device.The patient was stable post-procedure.However, returned device analysis revealed pinhole in the balloon.

• 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: 20735581
• Report Number: 2124215-2024-72655
• Device Sequence Number: 8363123
• Product Code: LOX
• UDI-Device Identifier: 08714729392699
• UDI-Public: 08714729392699
• 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
• Report Date (Section B): 11/20/2024

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: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0033840826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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