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

Model Number	24970
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 6f mach1 was advanced via a contralateral approach over the steep iliac bifurcation to assist in intravascular ultrasound (ivus) supported by a non-bsc sheath.However, during ivus catheter removal, it felt like it was stuck and was removed forcibly.The mach1 was then attempted to be removed but it was stuck inside the non-bsc sheath.It could not be removed even by pulling forcibly, and the mach 1 broke.The device was completely removed from the patient's body together with the non-bsc sheath.The procedure was completed with another system.No patient complications were reported.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10020502
• Report Number: 2134265-2020-05965
• Device Sequence Number: 2592767
• Product Code: DQY
• UDI-Device Identifier: 08714729403531
• UDI-Public: 08714729403531
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2020

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 Expiration Date: 08/22/2022
• Device Model Number: 24970
• Device Catalogue Number: 24970
• Device Lot Number: 0060202496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1