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

Model Number	1260
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guide catheter broke.A mach 1 guide catheter was selected as part of treatment of the target lesion.After the guide catheter was advanced, it was noticed that the distal end had come off.The disconnected part of the catheter was still on the guidewire and was able to be removed with the guidewire.The device was removed fully by pulling it normally out.Another of the same device was then used to complete the procedure successfully.No complications were reported, and patient condition is normal post procedure.
Additional Manufacturer Narrative
The returned product consisted of the mach1 guide catheter along with an unknown guidewire.A visual inspection revealed that the shaft of the device was twisted and detached.5mm distal of the strain relief of the hub.There was exposed braiding at the twisted and detached shaft.The shaft was also kinked 72.5cm distal of the strain relief of the hub.When functional testing was attempted to be performed, the hub was able to be removed from the unknown guidewire with no issues or resistance.As the device was used past unpackaging, this means the device passed inspection by the facility when removed from the packaging, before use with no potential indicators of any damage or any issues that could contribute to the reported event.As a result, the event most likely happened due to probable causes related to the procedure or the patient anatomy.As it was reported that the event occurred when rotating the device into the lesion, it most likely the event was caused during the procedure from handling the device during interaction with another device or the patients anatomy.Therefore, based on a thorough review of the reported complaint, the most probable cause for this complaint was considered adverse event related to procedure.
Event or Problem Description
It was reported that the guide catheter broke.A mach 1 guide catheter was selected as part of treatment of the target lesion.After the guide catheter was advanced, it was noticed that the distal end had come off.The disconnected part of the catheter was still on the guidewire and was able to be removed with the guidewire.The device was removed fully by pulling it normally out.Another of the same device was then used to complete the procedure successfully.No complications were reported, and patient condition is normal post procedure.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22114797
• Report Number: 2124215-2025-35250
• Device Sequence Number: 20627043
• Product Code: DQY
• UDI-Device Identifier: 08714729351177
• UDI-Public: (01)08714729351177(17)271209(10)60611287
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060611287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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