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

Model Number Version 1.0

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2021

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG
• MDR Report Key: 12561869
• MDR Text Key: 274538316
• Report Number: MW5104316
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810292
• UDI-Public: (01)07640142810292(17)230708
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 82