MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREX S 6F 135 CM ATHERECTOMY STRAUB MEDICAL; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	Version 1.0
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent aortogram and left leg arteriogram in my office based cath lab today.During attempted atherectomy of a complete occlusion of the left superficial femoral artery with a straub medical rotarex 6f atherectomy device, the device broke, leaving the cutter head and a long piece of the driving apparatus inside the patient.Attempts to snare and retrieve the broken fragment via the existing right common femoral artery access were unsuccessful.The device was ultimately snared and retrieved successfully via a 2nd sheath placed in the left common femoral artery, but a stent that was placed in the left external iliac artery during the same procedure was also inadvertently retrieved with the device.Fda safety report id # (b)(4).

• Brand Name: ROTAREX S 6F 135 CM ATHERECTOMY STRAUB MEDICAL
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG
• MDR Report Key: 12561869
• Report Number: MW5104316
• Device Sequence Number: 4111935
• Product Code: MCW
• UDI-Device Identifier: 07640142810292
• UDI-Public: (01)07640142810292(17)230708
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 07/06/2023
• Device Model Number: Version 1.0
• Device Catalogue Number: 80201
• Device Lot Number: 200801
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Weight: 82