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

Model Number	1260
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that cardiac arrest and distal tip damaged occurred.A mach1 diagnostic guide catheter was selected for use in a coronary intervention procedure.The distal tip was crushed damaged and a blood clot has occurred, the blood flow was temporarily interrupted, resulting in cardiac arrest requiring hospital treatment.No further patient complications were reported.
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Initial reporter city: (b)(6).
Additional Manufacturer Narrative
Correction to h6 device code.Initially reported as a fracture.Supplement mdr is correcting h6 code to material integrity problem.Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that cardiac arrest and distal tip damage occurred.A mach1 diagnostic guide catheter was selected for use in a coronary intervention procedure.The distal tip was crushed damaged and a blood clot has occurred, the blood flow was temporarily interrupted, resulting in cardiac arrest requiring hospital treatment.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the model-6f mach 1 q3.5 sh (side holes) was returned for analysis.Visual and microscopic observation was performed on the catheter hub, shaft, and distal tip.A kink was identified approximately 6.5 cm from the distal tip and the distal tip was identified damaged/crushed.No further damaged were observed.Correction to h6 device code.Initially reported as fracture.Supplement mdr is correcting h6 code to material integrity problem.Initial reporter address 1: (b)(6); e1 initial reporter city: (b)(6).
Event or Problem Description
It was reported that cardiac arrest and distal tip damaged occurred.A mach1 diagnostic guide catheter was selected for use in a coronary intervention procedure.The distal tip was crushed damaged and a blood clot has occurred, the blood flow was temporarily interrupted, resulting in cardiac arrest requiring hospital treatment.No further patient complications were reported.

• 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: 15370975
• Report Number: 2124215-2022-34612
• Device Sequence Number: 13884618
• Product Code: DQY
• UDI-Device Identifier: 08714729351337
• UDI-Public: 08714729351337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2024
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060311978
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 09/05/2022; 10/11/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 09/29/2022; 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown