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

Model Number	1260
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Blood was inside the device.Inspection of the device revealed that approximately 99cm of the shaft (including tip) was returned for analysis.The shaft was detached near the hub strain relief and the hub/strain relief were not returned for analysis.The detached end of the shaft was twisted/damaged with exposed braiding.The media consisted of three (3) photos showed the mach1 shelf box with the label, confirming the batch number, and the word defective written on it.There were no photos of the device in the media.So, the media was not able to confirm the reported event.
Event or Problem Description
Reportable based on the device analysis completed on 17nov2025.It was reported that the device was defective.A 6f mach 1 was selected for use.During inspection of the pulled-out items, it was noted that the unit was marked as defective.However, the device analysis revealed that the shaft was detached.

• 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: 23743402
• Report Number: 2124215-2025-89551
• Device Sequence Number: 8469520
• Product Code: DQY
• UDI-Device Identifier: 08714729351986
• UDI-Public: (01)08714729351986(17)251227(10)60424387
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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: Other
• Device Expiration Date: 12/27/2025
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060424387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2022
• 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