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

Model Number ROTAREX S 6 F 135 CM

Device Problems Break (1069); 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 male patient came in as an outpatient to have a peripheral angiography and le angiogram for occlusive arterial vascular disease.Peripheral interventions were needed due to arterial claudication/stenosis.During the rotational atherectomy of the left superficial femoral artery, on the third pass, the wire tip (guidewire) fractured and the device had to be snared out.An hour later, the internal spring of the guidewire broke off in the body of the helex.The retrieval process was successful though it took 1.5 hours to retrieve and the device was removed in total.The patient had no complaints and no pain, no harm came to the patient.The patient was discharged to home later this same day.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: 12312972
• MDR Text Key: 266402751
• Report Number: MW5103184
• 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 6 F 135 CM
• Device Catalogue Number: REF: 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: 66 YR