MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MACH1; CATHETER, PERCUTANEOUS

Model Number	1260
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tip fracture occurred.While unpacking a 6f mach 1 cls3.5 guide catheter, a tip fracture occurred.No patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluated by manufacturer: visual and microscopic observation was performed on device.There were numerous kinks on shaft; however, tip was observed to have no fracture.No other abnormalities were observed.The reported events cannot be confirmed as tip was observed to be intact and with no fracture.
Event or Problem Description
It was reported that a tip fracture occurred.While unpacking a 6f mach 1 cls3.5 guide catheter, a tip fracture occurred.No patient complications were reported in relation to this event.It was further reported that the catheter tip was broken while it was unpacked and was not used on the patient.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15047831
• Report Number: 2134265-2022-07976
• Device Sequence Number: 12090661
• Product Code: DQY
• UDI-Device Identifier: 08714729350644
• UDI-Public: 08714729350644
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K020028
• 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): 08/06/2022

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: 10/08/2024
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060323622
• 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: 06/28/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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: Unknown