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

Model Number	1770
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device detachment occurred.An 8f mach 1 guide catheter was selected for use.After the procedure was completed, a small ring-shaped object was observed floating in the left ventricle.The physician thought that the tip of the guide catheter had fallen off.The procedure had been completed with this device.No further patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic observation revealed that the device tip was intact.No additional device damage identified on device.Media provided by the site was reviewed and found to show no damage to the device and the device tip appeared intact.
Event or Problem Description
It was reported that device detachment occurred.An 8f mach 1 guide catheter was selected for use.After the procedure was completed, a small ring-shaped object was observed floating in the left ventricle.The physician thought that the tip of the guide catheter had fallen off.The procedure had been completed with this device.No further patient complications were reported.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18754497
• Report Number: 2124215-2024-05636
• Device Sequence Number: 6337892
• Product Code: DQY
• UDI-Device Identifier: 08714729383772
• UDI-Public: 08714729383772
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: 10/13/2024
• Device Model Number: 1770
• Device Catalogue Number: 1770
• Device Lot Number: 0060325287
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• 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: Other
• Patient Sex: Unknown