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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
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 90% stenosed, 3x28mm, concentric, de novo target lesion with a bend of 45 degrees was located in the mildly tortuous and severely calcified left circumflex artery.A 4.0mm x 12mmn quantum maverick balloon catheter was advanced for dilation.However, during inflation, the balloon burst.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable.
Additional Manufacturer Narrative
(e1) initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 3x28mm, concentric, de novo target lesion with a bend of <=45 degrees was located in the mildly tortuous and severely calcified left circumflex artery.A 4.0mm x 12mmn quantum maverick balloon catheter was advanced for dilation.However, during inflation, the balloon burst.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable.It was further reported that balloon ruptured during second inflation at 18 atmospheres for 15 seconds.
Additional Manufacturer Narrative
(e1) initial reporter phone: (b)(6).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The device was visually and microscopically examined.There was separation of the hypotube at 71.9cm from strain relief.There were no fluids present to the device and the balloon was tightly folded.From the separation, the distal end of the device was connected to a touhy and prepped with a new inflation device filled with water to inflate the device to the rated burst pressure.The device inflated and deflated to rated burst pressure with no issue or irregularity.Product analysis did not confirm the reported event as during functional testing the balloon inflated to rated burst pressure and deflated with no issues.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 3x28mm, concentric, de novo target lesion with a bend of <=45 degrees was located in the mildly tortuous and severely calcified left circumflex artery.A 4.0mm x 12mmn quantum maverick balloon catheter was advanced for dilation.However, during inflation, the balloon burst.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable.It was further reported that balloon ruptured during second inflation at 18 atmospheres for 15 seconds.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17207068
• Report Number: 2124215-2023-33294
• Device Sequence Number: 6666499
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2023

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: 11/02/2023
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0026284307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/02/2023; 08/21/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/10/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 50 KG