MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL); ATHERECTOMY CATHETER

Model Number SET ROTAREX®S 6F X 135CM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fistula (1862); Perforation of Vessels (2135); Thromboembolism (2654)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

Device was discarded at the hospital.Investigation was performed without the device.

Event Description

Ifurcation was not problematic, began to atherectomize cto interlumenare.Catheter clutched up in two spots.Stopped atherectomizing, removed the device.Cleared in saline bowl.Shot contrast and noticed that the av fistula that was in the distal cap of cto.Upon catheter passing below the knee, noticed spasm and thrombus.Asked physician if possible to perform act, however physician was able to do ptinr.Av fistula resolved with lifestream covered stent.Continued angioplasty in lesion.Jet-stream device was used to clear thrombus.Perforation was noticed in popliteal.Then completed case.Thrombolytics was administered overnight.Discovered that patient did not receive enough heparin.Patient was transferred to another hospital for care.Patient then received below the knee amputation.It was stated that the patient did not receive proper amount of anticoagulation medication (heparin).Patient status is stable.

• Brand Name: ROTAREXS 6F 135CM (STRAUB MEDICAL)
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• Manufacturer (Section G): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• Manufacturer Contact: martin kvokacka ; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 11042720
• MDR Text Key: 222643106
• Report Number: 3008439199-2020-00070
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: 7640142810582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2023
• Device Model Number: SET ROTAREX®S 6F X 135CM
• Device Catalogue Number: 80237
• Device Lot Number: 200772
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability