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

Model Number	24970
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was aborted.The 99% stenosed target lesion was located in the severely tortuous forearm.A 6f mach 1 catheter-guide was used in a vascular access intervention therapy (vaivt) of chronic renal failure.During procedure, it was noted that the guidewire was unable to pass through, and the device was unable to support the system.The procedure was cancelled/rescheduled due to this issue.There was no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned device consisted of a mach 1 guide catheter.Analysis of the tip and shaft included microscopic and visual inspection.Inspection revealed shaft damage (flattened) located 19.7cm from the tip of the device.Inspection of the rest of the device found no other damage or defect.The complaint device was not returned with the guide wire used in the procedure, so a lab supplied wire was used to functionally test the device.The guide wire was inserted into the hub of the catheter and advanced through the shaft and out of the tip.The wire advanced easily and without issue.The reported wire difficulty was not confirmed.
Event or Problem Description
It was reported that the procedure was aborted.The 99% stenosed target lesion was located in the severely tortuous forearm.A 6f mach 1 catheter-guide was used in a vascular access intervention therapy (vaivt) of chronic renal failure.During procedure, it was noted that the guidewire was unable to pass through, and the device was unable to support the system.The procedure was cancelled/rescheduled due to this issue.There was no patient complications 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: 10314497
• Report Number: 2134265-2020-09730
• Device Sequence Number: 19555634
• Product Code: DQY
• UDI-Device Identifier: 08714729403500
• UDI-Public: 08714729403500
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/28/2020

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: 10/28/2022
• Device Model Number: 24970
• Device Catalogue Number: 24970
• Device Lot Number: 0060212649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1