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

Model Number	7590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the mid circumflex (cx).A 2.50 x 20mm maverick balloon, was advanced to the target lesion, but while inflating the balloon, the device broke in three pieces.It was noted that the break occurred in between the stenosis.The device broke in several pieces during inflation of the device.It was noted that the device broke without any visible reason.The device was removed from the patient.The procedure was completed with another of the same device without any problem for the patient.There were no patient complications reported in relation to this event.
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the mid circumflex (cx).A 2.50 x 20mm maverick balloon, was advanced to the target lesion, but while inflating the balloon, the device broke in three pieces.It was noted that the break occurred in between the stenosis.The device broke in several pieces during inflation of the device.It was noted that the device broke without any visible reason.The device was removed from the patient.The procedure was completed with another of the same device without any problem for the patient.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of a maverick 2 mr balloon catheter.The device was visually and microscopically examined.There was blood and contrast in the manifold of the device, and a bend in the strain relief.At 62.5cm and 90cm from the strain relief there were two separations of the hypotube.The separated ends were jagged and ovaled in shape indicating the device was kinked prior to separation.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded, and blood was present in the folds.Product analysis confirmed the reported break as there were two separations to the hypotube of the device and a bend in the strain relief.
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the mid circumflex (cx).A 2.50 x 20mm maverick balloon, was advanced to the target lesion, but while inflating the balloon, the device broke in three pieces.It was noted that the break occurred in between the stenosis.The device broke in several pieces during inflation of the device.It was noted that the device broke without any visible reason.The device was removed from the patient.The procedure was completed with another of the same device without any problem for the patient.There were no patient complications reported in relation to this event.

• Brand Name: 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13535711
• Report Number: 2134265-2022-01635
• Device Sequence Number: 17430157
• Product Code: LOX
• UDI-Device Identifier: 08714729370185
• UDI-Public: 08714729370185
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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: 02/11/2024
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0026791028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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
• Patient Sex: Unknown