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

Model Number	7005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified left anterior descending artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, when the device was advanced halfway in the guiding catheter, the shaft broke in two pieces at 55cm from the hub.The fractured part was completely retrieved through the guiding catheter.The procedure was completed with another of same device.There were no patient complications reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The device was microscopically and visually examined.The hypotube of the device has numerous kinks.There was a separation 49.5cm from the strain relief.There was blood in the guidewire lumen.The tightly folded balloon had contrast and blood present in the folds.There was tip damage to the device.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported break as there was separation to the device.The device also had numerous kinks to the device.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified left anterior descending artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, when the device was advanced halfway in the guiding catheter, the shaft broke in two pieces at 55cm from the hub.The fractured part was completely retrieved through the guiding catheter.The procedure was completed with another of same device.There were no patient complications reported and the patient was fine.

• 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: 11607492
• Report Number: 2134265-2021-03470
• Device Sequence Number: 3291981
• Product Code: LOX
• UDI-Device Identifier: 08714729392569
• UDI-Public: 08714729392569
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 08/18/2022
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0024285748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1