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

Model Number	1260
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Difficult to Remove (1528); Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.
Event or Problem Description
It was reported that the shaft hole, break and blood leakage occurred.A 6f mach1 guide catheter was selected for use.During advancement of the wire, a small hole was noted at the flush end of the catheter.The wire was inadvertently passing through this hole, resulting in blood leakage.Removal required twisting, and the catheter end subsequently snapped.There no patient complication reported.
Event or Problem Description
It was reported that the shaft hole, break and blood leakage occurred.A 6f mach1 guide catheter was selected for use.During advancement of the wire, a small hole was noted at the flush end of the catheter.The wire was inadvertently passing through this hole, resulting in blood leakage.Removal required twisting, and the catheter end subsequently snapped.There no patient complication reported.It was further reported that the target lesion was located in a severely tortuous lesion.A hole was identified in the distal portion of the catheter, outside the body, where it connects to the pressure line.Difficulty was encountered during device removal, and the distal end of the catheter was cut with scissors to allow the wire retrieved from the patient.The procedure successfully completed with another device, and the patient was well post procedure.
Additional Manufacturer Narrative
B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.

• 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: 23819316
• Report Number: 2124215-2025-91169
• Device Sequence Number: 21184600
• Product Code: DQY
• UDI-Device Identifier: 08714729351153
• UDI-Public: (01)08714729351153(17)280127(10)60619148
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: 0060619148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/15/2026
• Date Device Manufactured: 01/27/2025
• 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