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

Model Number	7015
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed and completed the procedure with another of same device.There were no patient complications reported.Patient was stable.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter address 1:(b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed and completed the procedure with another of same device.There were no patient complications reported.Patient was stable.It was further reported that the balloon was initially inflated at 10 atmospheres but ruptured on the second inflation at 12 atmospheres.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.Visual inspection revealed an 8mm longitudinal tear in the shaft 1mm proximal from the proximal waist of the balloon.Microscopic inspection revealed no further damage or irregularity.There was contrast in the inflation lumen and the loosely folded balloon.There was blood in the hub, inflation and guidewire lumen, and the balloon.E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed and completed the procedure with another of same device.There were no patient complications reported.Patient was stable.It was further reported that the balloon was initially inflated at 10 atmospheres but ruptured on the second inflation at 12 atmospheres.

• 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: 19223010
• Report Number: 2124215-2024-25846
• Device Sequence Number: 8194798
• Product Code: LOX
• UDI-Device Identifier: 08714729392767
• UDI-Public: 08714729392767
• 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,Followup
• Report Date (Section B): 06/21/2024

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: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0032730154
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 05/05/2024; 06/11/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/08/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 70 KG