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

Model Number	962
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).(b)(4).
Event or Problem Description
It was reported that tip detachment occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending.A mach1 guide catheter was selected for use.During percutaneous coronary intervention (pci), when the ivus catheter was pulled outside the body after lesion evaluation, it was noted that it got pulled out with deflection between the ivus catheter and guidewire.The tip of the guide catheter was stuck.Difficulty on pulling the system outside the body was avoided.However, the tip of the guide catheter broke.The ivus catheter was tried to use again, but the image did not display, and it seemed that lost image occurred.The procedure was completed with different device of the same model.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: 8478276
• Report Number: 2134265-2019-03377
• Device Sequence Number: 19258580
• Product Code: DQY
• UDI-Device Identifier: 08714729119203
• UDI-Public: 08714729119203
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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: 05/04/2021
• Device Model Number: 962
• Device Catalogue Number: 962
• Device Lot Number: 0060124370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1