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

Lot Number 221576

Patient Problem Foreign Body In Patient (2687)

Event Date 01/24/2024

Event Type  Injury  

Event Description

Rotarex atherectomy and thrombectomy device.The device fractured the guidewire included in the rotarex kit resulting in wire fragments being trapped inside the patient.

• Brand Name: ROTAREX S 6F X 135CM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG
• MDR Report Key: 18606487
• MDR Text Key: 334200080
• Report Number: MW5150866
• 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: Physician
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 221576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White