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

Model Number	1260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the device was broken.Vascular access was obtained via radial artery, 2.50 mm moderately tortuous was located in the left circumflex artery.A mach guide catheter was selected for use.During the coronary angioplasty the guide catheter was broken.The procedure was completed with another of same device.No patient complications were reported and the patients status was stable.
Event or Problem Description
It was reported that the device was broken.Vascular access was obtained via radial artery, 2.50mm moderately tortuous was located in the left circumflex artery.A mach guide catheter was selected for use.During the coronary angioplasty the guide catheter was broken.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.Device evaluated by manufacturer; analysis of the tip and shaft included microscopic and visual inspection.Inspection revealed a kink in the shaft located 15mm from the tip of the device.Inspection found no other damage or defect with the device.The reported damaged device was confirmed.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10459867
• Report Number: 2134265-2020-11790
• Device Sequence Number: 2939168
• Product Code: DQY
• UDI-Device Identifier: 08714729350644
• UDI-Public: 08714729350644
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 04/04/2022
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060179893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1