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

Model Number	24970
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Initial reporter city: (b)(6).
Event or Problem Description
It was reported that a tip detachment occurred.A 6f mach1 guide catheter was selected for use in a treatment procedure.The target 50% stenosed target lesion was located in a moderately tortuous right superficial femoral artery.It was observed that the tip was detached.The device was not used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).E1: initial reporter city: (b)(6).The device was returned for analysis.Visual inspection revealed the shaft and tip were visually examined.Inspection of the device revealed that the tip was attached to the shaft and was not detached, as reported.The shaft was found to have been kinked and flattened just proximal of the tip.
Event or Problem Description
It was reported that a tip detachment occurred.A 6f mach1 guide catheter was selected for use in a treatment procedure.The target 50% stenosed target lesion was located in a moderately tortuous right superficial femoral artery.It was observed that the tip was detached.The device was not 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: 12200027
• Report Number: 2134265-2021-09315
• Device Sequence Number: 1494296
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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: 06/26/2023
• Device Model Number: 24970
• Device Catalogue Number: 24970
• Device Lot Number: 0060246532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1