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

Model Number ROTAREX®S 6F 135CM

Device Problems Fracture (1260); Overheating of Device (1437); Component Missing (2306)

Patient Problems Stenosis (2263); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2020

Event Type  malfunction  

Manufacturer Narrative

Suspect device not returned yet.The return of suspect device is expected.

Event Description

Left groin treating right leg.No access issues, no concern about case.Cto distal sfa, disease in common femoral.Crossed cto easily.Used ivis.Used rotarex in common fem, moved to distal sfa.2/3 the way through hit "rock", 80% stenosed.Bogged down.Clutched out twice, then pushed past the stenosis to treat farther down.Back and forth motion peck motion.Moved away and down tpt drunk.Noticed slower aspiration but working normal.Removed device, set aside, didn't notice tip was missing from device.Rotarex catheter fracture when crossing the bifurcation.Trouble putting balloon into sheath.Looked at flouro - saw helix inside of sheath, still on wire but distal to sheath.Used snare to remove device.Fragment was 1/3 of helix length.All got pushed out distal to sheath when balloon was put in.Added ~3min to case to retreive device.7fr cook ansel sheath, not a high flex.When wire pinned, when finishing up and getting ready to pull device out (finishing distal tpt trunk), the wire started to feel warm.Device running when removed through cto.

Manufacturer Narrative

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

• 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
• MDR Report Key: 10791987
• MDR Text Key: 217958942
• Report Number: 3008439199-2020-00054
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810261
• UDI-Public: 7640142810261
• Combination Product (y/n): N
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: ROTAREX®S 6F 135CM
• Device Catalogue Number: 80237
• Device Lot Number: 200600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention