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

Model Number	1260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the device fractured.Two mach 1 guide catheters were selected for use in a coronary angiography procedure.During unpacking, the distal ostium was noted to be fractured.No damage was noted during visual or at package for transport.Another of the same device was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Mfr site address 2: (b)(4).Device evaluated by mfr: returned product consisted of a 6f mach1 guide catheter.The tip, shaft and hub were microscopically and visually inspected.Inspection revealed tip damage (flattened), and shaft kinks located 6mm and 17mm from the tip of the device.Inspection of the rest of the device found no other damage or irregularities.
Event or Problem Description
It was reported that the device fractured.Two mach 1 guide catheters were selected for use in a coronary angiography procedure.During unpacking, the distal ostium was noted to be fractured.No damage was noted during visual or at package for transport.Another of the same device was used to complete the procedure.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: 8546554
• Report Number: 2134265-2019-04291
• Device Sequence Number: 16233263
• Product Code: DQY
• UDI-Device Identifier: 08714729352082
• UDI-Public: 08714729352082
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: 01/21/2022
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060168074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/10/2019
• Patient Sequence Number: 1