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	04/01/2021
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 severely tortuous and mildly to moderately calcified right coronary artery.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during first inflation at 12 atmospheres for 20 seconds, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the severely tortuous and mildly to moderately calcified right coronary artery.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during first inflation at 12 atmospheres for 20 seconds, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The device was microscopically and visually examined.There was blood present in the manifold.There was contrast and blood present in the inflation lumen and balloon.There was blood in the guidewire lumen.The balloon was loosely folded and not fully deflated, and the tip of the device was damaged.The device was soaked for an extended period of time to break up the blood and contrast within the device.It was then prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device inflated to rated burst pressure however the balloon did not inflate or deflate.The device was then soaked further as part of the inflation lumen appeared to still have hardened blood.Inflation was tried again and had the same outcome of the balloon not inflating or deflating.The device was then bent apart by cis at the hypotube to inflate at a different section of the hypotube using a stopcock and the inflation device.Again, the same outcome was present.The balloon was lightly compressed to see if any fluid would extract from the balloon and that failed.Because the balloon would not inflate or deflate, and no fluid would extract from the device there is no further testing that could be completed.Product analysis could not confirm the reported burst, as during functional testing there was no evidence the device had burst aside from blood content found throughout the device.All testing capabilities could not prove a hole was present in the balloon or the shaft of the device due to the amount of blood and contrast within the device.

• 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
• MDR Report Key: 12065332
• Report Number: 2134265-2021-08125
• Device Sequence Number: 4765063
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2021

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: 02/03/2023
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0025152025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 65