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

Model Number	24974
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device almost broke.A mach 1 catheter guide was selected for use.The intended lesion was located in the right carotid artery.During the procedure, the physician had difficulty moving the device inside the arteries.When moving the device, it almost broke inside the patient due to the weakness in the middle of the catheter.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The catheter shaft was inspected for damage.The catheter shaft showed 1 kink located 48cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the device almost broke.A mach 1 catheter guide was selected for use.The intended lesion was located in the right carotid artery.During the procedure, the physician had difficulty moving the device inside the arteries.When moving the device, it almost broke inside the patient due to the weakness in the middle of the catheter.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10607257
• Report Number: 2134265-2020-13544
• Device Sequence Number: 14153826
• Product Code: DQY
• UDI-Device Identifier: 08714729481591
• UDI-Public: 08714729481591
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,Followup
• Report Date (Section B): 10/28/2020

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: 06/20/2022
• Device Model Number: 24974
• Device Catalogue Number: 24974
• Device Lot Number: 0060191530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/13/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 50