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	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient was hospitalized due to acute myocardial infarction.Following the consent of the family, an emergency percutaneous coronary intervention (pci) was being performed.The 90% stenosed target lesion was located in the non-tortuous and non-calcified left circumflex artery.After the stent was placed, a 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during the third inflation at 14 atmospheres for 5 seconds, the balloon burst.Neither the balloon nor a segment of the balloon detached inside the patient after it burst.The procedure was completed with another of the same device.During the procedure, the physician suspected myocardial staining and vascular rupture.The patient then underwent an ultrasound.Pericardial effusion nor blooding was not found during the ultrasound.After an hour of observation, ultrasound re-examination was performed and nothing abnormal was detected.The blood vessels were unobstructed, no leakage was observed, and the patient was not affected.The patient was sent back to the ward for further observation.No patient complications were reported, and 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: 18261487
• Report Number: 2124215-2023-68503
• Device Sequence Number: 7672718
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: 08714729392781
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2023

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: 05/24/2026
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0031690620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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: 41 YR
• Patient Sex: Male