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

Model Number	1260
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	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an estimate based on aware date as event date is unknown.Device evaluated by mfr: the returned product consisted of the mach1 guide catheter.The hub, shaft, and tip were visually and microscopically examined.Blood was present inside the hub and shaft.Inspection of the device revealed that shaft was twisted with damaged braiding and detached at the end of the strain relief.The shaft was also kinked 1.7cm distal of the strain relief.
Event or Problem Description
Reportable based on device analysis completed on december 01, 2021.It was reported that the hub detached.A percutaneous coronary intervention was being performed.This mach1 guide catheter was selected while mildly torqueing the device to engage the coronaries the hub detached and twisted off.No patient complications were reported.However device analysis identified a detachment at the end of the strain relief.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; noblestraat 10 14; oostrum lb 5807 GA; NL 5807 GA
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12963900
• Report Number: 2134265-2021-15602
• Device Sequence Number: 1751218
• Product Code: DQY
• UDI-Device Identifier: 08714729350644
• UDI-Public: 08714729350644
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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: 07/05/2024
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060306517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown