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

Model Number	24973
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip break occurred.The patient underwent an arteriovenous fistula thrombectomy.A two 90cm mach 1 cather-guide were selected for use.During the preparation, after opening the product, it was noted that the tip part of the device was broken.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that the tip break occurred.The patient underwent an arteriovenous fistula thrombectomy.A two 90cm mach 1 cather-guide were selected for use.During the preparation, after opening the product, it was noted that the tip part of the device was broken.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the device was just pulled out from the cardboard packaging.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The shaft and tip was visually inspected.Visual examination revealed damage to the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported damage to the tip.

• 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: 19524897
• Report Number: 2124215-2024-33686
• Device Sequence Number: 6333763
• Product Code: DQY
• UDI-Device Identifier: 08714729403821
• UDI-Public: 08714729403821
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/14/2024

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: 24973
• Device Catalogue Number: 24973
• Device Lot Number: 0060527600
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female