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

Model Number	1260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located at the moderately tortuous distal left circumflex.During percutaneous coronary intervention, a mach 1 catheter guide was selected for use.However, engage was weak and when wire was manipulated in order to cross the lesion, it got separated.The device was replaced with a different device.No patient complications nor injuries 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: 7894358
• Report Number: 2134265-2018-61169
• Device Sequence Number: 1936453
• Product Code: DQY
• UDI-Device Identifier: 08714729350682
• UDI-Public: 08714729350682
• 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): 09/20/2018

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: 02/17/2021
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060113015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/20/2018
• Patient Sequence Number: 1