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

Model Number	7010
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The target lesion was located in the mildly tortuous and mildly calcified left main artery.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, during the first inflation at 6 atmospheres, the balloon ruptured and the shaft was separated in two pieces 80 centimeters from the hub.The device was removed by snaring and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The target lesion was located in the mildly tortuous and mildly calcified left main artery.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, during the first inflation at 6 atmospheres, the balloon ruptured and the shaft was separated in two pieces 80 centimeters from the hub.The device was removed by snaring and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Returned product consisted of the quantum maverick balloon catheter.The device was visually and microscopically examined.There were numerous kinks in the hypotube.There was separation of the hypotube at 76.4cm from the strain relief.The separated ends of the hypotube were oval shaped indicating that the device was kinked prior to separation.There was contrast in the inflation lumen and blood present in the guidewire lumen.The balloon was tightly folded, and the tip of the device was damaged.The distal portion of the device was soaked in a water bath to break up contrast in the device and was then connected to a touhy and prepped with an inflation device filled with water to inflate the device to the rated burst.The balloon was able to be inflated to rated burst pressure, as well as deflate with no issues.

• Brand Name: QUANTUM MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12808170
• Report Number: 2134265-2021-14162
• Device Sequence Number: 5511608
• Product Code: LOX
• UDI-Device Identifier: 08714729392675
• UDI-Public: 08714729392675
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: 02/26/2024
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0026880752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 11/13/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 74 KG