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

Model Number	7575
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 2.00mm x 9mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the shaft was broken at the middle segment.The broken device was simply pulled out and the procedure was completed with a non-boston scientific device.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr.: returned product consisted of a maverick 2mr balloon catheter.The device was visually and microscopically examined.The device was returned with the balloon protector and shipping mandrel in their respective places on the device of which were removed without issue or irregularity.There was a separation of the hypotube 20.8cm from the strain relief.There were numerous kinks and bends to both the hypotube and shaft of the device.There was contrast in the inflation lumen and the balloon.The balloon was loosely folded.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 2.00mm x 9mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the shaft was broken at the middle segment.The broken device was simply pulled out and the procedure was completed with a non-boston scientific device.There were no patient complications reported.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17289774
• Report Number: 2124215-2023-35799
• Device Sequence Number: 5523525
• Product Code: LOX
• UDI-Device Identifier: 08714729369875
• UDI-Public: 08714729369875
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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: 07/27/2025
• Device Model Number: 7575
• Device Catalogue Number: 7575
• Device Lot Number: 0029845207
• 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: 07/01/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• 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
• Patient Race: Asian