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	06/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.00mm x 9mm maverick balloon catheter was advanced for pre-dilation.However, during procedure, the shaft broke.The procedure was completed with another of same device.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 microscopically and visually examined.The hypotube and shaft of the device has numerous kinks.At 47.8cm from the strain relief the hypotube was separated.The separated ends of the hypotube were ovaled in shape indicating it was kinked prior to separation.At 59.7cm distal from the separation, the inflation lumen was stretched, kinked, and twisted for a length of 17.8cm.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded and had blood and contrast in the folds.Product analysis confirmed the reported event as there was separation to the hypotube.
Event or Problem Description
It was reported that shaft break occurred.A 2.00mm x 9mm maverick balloon catheter was advanced for pre-dilation.However, during procedure, the shaft broke.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
• MDR Report Key: 12203841
• Report Number: 2134265-2021-09345
• Device Sequence Number: 19890485
• 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
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: 09/10/2022
• Device Model Number: 7575
• Device Catalogue Number: 7575
• Device Lot Number: 0024410783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1