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

Model Number ROTAREX S 6F 135 CM

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  Injury  

Event Description

A (b)(6) yo with severe aortoiliac disease presented for planned angiogram due to calf claudication.Patient with h/o cad, copd, hld, htn, recent stemi, occluded left iliac stent (stent placed (b)(6) 2018).During the third pass with a rotarex atherectomy device (in the left common and external iliac artery), the device tip fractured while still inside the iliac artery.To retrieve the tip, the physician had to use an ensnare device to remove the broken piece from the artery.The patient had no complaints, no pain and no harm came to the patient.Fda safety report id # (b)(4).

• Brand Name: ROTAREX S 6F 135 CM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG
• MDR Report Key: 12312959
• MDR Text Key: 266402848
• Report Number: MW5103183
• Device Sequence Number: 1
• Product Code: MCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: ROTAREX S 6F 135 CM
• Device Catalogue Number: REF NUMBER: 80237
• Device Lot Number: 201120
• Was Device Available for Evaluation?: No
• 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): Required Intervention
• Patient Age: 56 YR