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

Model Number 24974

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2020

Event Type  malfunction  

Event 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.

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 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
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10607257
• MDR Text Key: 209206599
• Report Number: 2134265-2020-13544
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729481591
• UDI-Public: 08714729481591
• Combination Product (y/n): N
• PMA/PMN Number: K020028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 50