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

Model Number	7580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The patient presented with chest pain, and a percutaneous coronary angioplasty was performed on the right coronary artery (rca).A 2.50mm x 12mm maverick balloon was selected for treatment, but an accidental breakage at the junction of the balloon hypotube and shaft occurred.The fractured balloon was inside the guide catheter, which was inside the patient.The balloon device was removed together with the guide catheter.The procedure was completed with another of the same device.No patient complications resulted in relation to this event, and the patient was reported to be doing well.
Additional Manufacturer Narrative
E1 initial reporter first name, initial reporter last name: corrected the returned product consisted of a maverick 2 mr balloon catheter.The device was visually and microscopically examined.At 49.8cm from the strain relief, the hypotube of the device was separated.The separated ends were ovaled in shape indicating the device was likely kinked prior to separation.There was blood in the guidewire lumen and inflation lumen, and the balloon was loosely folded.Photo media provided by the client was reviewed and found to be aligned to what was seen in product analysis as the separation was found in both analysis, and media review.
Event or Problem Description
It was reported that a shaft break occurred.The patient presented with chest pain, and a percutaneous coronary angioplasty was performed on the right coronary artery (rca).A 2.50mm x 12mm maverick balloon was selected for treatment, but an accidental breakage at the junction of the balloon hypotube and shaft occurred.The fractured balloon was inside the guide catheter, which was inside the patient.The balloon device was removed together with the guide catheter.The procedure was completed with another of the same device.No patient complications resulted in relation to this event, and the patient was reported to be doing well.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14680852
• Report Number: 2134265-2022-06772
• Device Sequence Number: 14805222
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: 08714729369981
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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: 12/01/2024
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0028485043
• 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: 05/25/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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: Male
• Patient Race: Asian