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

Model Number	7015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.A 3.0mm x 15mm quantum maverick balloon catheter was selected for use.However, during unpacking, it was noted that the shaft was broken.
Additional Manufacturer Narrative
A1.Patient identifier: (b)(6).Device evaluated by mfr.: the returned product consisted of a quantum maverick balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube at 53.1cm from the strain relief.The separated ends of the hypotube were ovaled in shape indicating the device was kinked prior to separation.There was contrast in the inflation lumen and balloon.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.A 3.0mm x 15mm quantum maverick balloon catheter was selected for use.However, during unpacking, it was noted that the shaft was broken.

• 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: 12345658
• Report Number: 2134265-2021-10613
• Device Sequence Number: 14437696
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: 08714729392781
• 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): 10/13/2021

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: 10/22/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0026230368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 65