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

Model Number	7010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that balloon fracture occurred and the patient experienced hypotension.The 50% stenosed, 4mm diameter target lesion was located in the tortuous and mildly calcified coronary vessel.A 4.0 x 20mm stent was implanted.A 4.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during inflation, the balloon material was broken into two parts from the middle inside the coronary vessel.The patient's blood pressure dropped, and dopamine was given to increase the blood pressure.Meanwhile, another guidewire and a non-boston scientific balloon catheter were used to remove the fractured balloon material from the patient.Subsequently, the vital signs of the patient gradually stabilized, and the patient was returned to the ward safely.The patient was stable.

• 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: 17493685
• Report Number: 2124215-2023-40114
• Device Sequence Number: 7822184
• Product Code: LOX
• UDI-Device Identifier: 08714729392712
• UDI-Public: 08714729392712
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2026
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0030800006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Male