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	01/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 83% stenosed target lesion was located in the left circumflex coronary artery.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the device was fractured.The device was completely removed and the procedure was completed with a different device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that shaft break occurred.The 83% stenosed target lesion was located in the left circumflex coronary artery.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the device was fractured.The device was completely removed and the procedure was completed with a different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick mr balloon catheter.The device was microscopically and visually examined.The hypotube of the device has numerous kinks.There was a separation 60.4cm from the strain relief.There was contrast in the folds of the tightly folded balloon.The device also had tip damage.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 11328006
• Report Number: 2134265-2021-00932
• Device Sequence Number: 13731917
• Product Code: LOX
• UDI-Device Identifier: 08714729392583
• UDI-Public: 08714729392583
• 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): 06/10/2021

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: 10/15/2022
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0024604116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 72