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	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 2.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, during procedure, the middle part of the shaft was cut off.The device was completely removed from the patient's body.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
D4: lot number: updated from 0027385598 to 0027381654.D4: expiration date: updated from 05/25/2024 to 05/24/2024.H4: device manufacture date: updated from 05/26/2021 to 05/25/2021.Device evaluated by mfr.: returned product consisted of a maverick 2 mr balloon catheter.The device was visually and microscopically examined.The hypotube and shaft of the device had numerous kinks.There was a separation of the hypotube at 89cm from the strain relief.The separated hypotube ends were 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.Photo media reviewed depicted the hypotube separation and a kink.This aligned with the separation found in analysis.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 2.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, during procedure, the middle part of the shaft was cut off.The device was completely removed from the patient's body.The procedure was completed with another of same device.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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13337915
• Report Number: 2134265-2022-00315
• Device Sequence Number: 14432872
• Product Code: LOX
• UDI-Device Identifier: 08714729370185
• UDI-Public: 08714729370185
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/15/2022

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: 05/24/2024
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0027381654
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• 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 Age: 68 YR
• Patient Sex: Female