MAUDE Adverse Event Report: BD / BARD PERIPHERAL VASCULAR, INC. ROTAREX ROTATIONAL EXCISIONAL ATHERECTOMY SYSTEM; CATHETER, PERIPHERAL, ATHERECTOMY

Lot Number 230893

Patient Problems Foreign Body In Patient (2687); Vascular Dissection (3160)

Event Date 01/24/2024

Event Type  Death  

Event Description

The patient was taken to ir for a right lower extremity angiogram.During the procedure, when in the process of treating the distal superficial femoral artery and popliteal artery occlusion, the rotarex atherectomy device malfunctioned.The surgeon attempted to remove the device endovascularly but was unsuccessful.Patient was taken to the hybrid operating room for a cutdown in an attempt for an open retrieval.The attempt to remove the foreign body caused a shearing tear likely at the aortic bifurcation.

• Brand Name: ROTAREX ROTATIONAL EXCISIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BD / BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 18659890
• MDR Text Key: 334814410
• Report Number: MW5151113
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 230893
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White