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	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A percutaneous transluminal coronary angioplasty was performed to left circumflex (lcx) and left anterior descending (lad) arteries.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified lad.After a 7f non-boston scientific (bsc) guide catheter was engaged and a non-bsc guidewire crossed the lesion, pre-dilation was performed in lcx with a 2.50 x 20mm maverick 2 balloon catheter.Following pre-dilation, a 3.00 x 28mm synergy was implanted and further post dilated.The same 2.50 x 20mm maverick 2 balloon catheter was tried to use for the lad; however, the shaft broke 27 inches from the proximal hub outside the y connector, outside the patient.The device was simply pulled out to remove it from the patient.The procedure was completed with a 2.50 x20 mm non -bsc balloon catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a maverick 2 mr balloon catheter.The device was visually and microscopically examined.The hypotube of the device has numerous kinks.There was a separation of the hypotube at 65.5cm from the strain relief.The separated hypotube ends were ovaled in shape indicating the device was kinked prior to separation.There was blood and contrast in the inflation lumen, and blood in the guidewire lumen.The balloon was loosely folded.The hypotube of the device also had numerous kinks.
Event or Problem Description
It was reported that shaft break occurred.A percutaneous transluminal coronary angioplasty was performed to left circumflex (lcx) and left anterior descending (lad) arteries.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified lad.After a 7f non-boston scientific (bsc) guide catheter was engaged and a non-bsc guidewire crossed the lesion, pre-dilation was performed in lcx with a 2.50 x 20mm maverick 2 balloon catheter.Following pre-dilation, a 3.00 x 28mm synergy was implanted and further post dilated.The same 2.50 x 20mm maverick 2 balloon catheter was tried to use for the lad; however, the shaft broke 27 inches from the proximal hub outside the y connector, outside the patient.The device was simply pulled out to remove it from the patient.The procedure was completed with a 2.50 x20 mm non -bsc balloon catheter.No patient complications were reported.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15123058
• Report Number: 2124215-2022-25534
• Device Sequence Number: 5601733
• Product Code: LOX
• UDI-Device Identifier: 08714729370185
• UDI-Public: 08714729370185
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 11/10/2023
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0026332813
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: VISTABRITE XB 7F 3.5; GUIDE CATHETER: VISTABRITE XB 7F 3.5; GUIDEWIRE: RUNTHROUGH NS HYPERCOAT; GUIDEWIRE: RUNTHROUGH NS HYPERCOAT; STENT: 3.00X28MM SYNERGY STENT; STENT: 3.00X28MM SYNERGY STENT
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: Asian