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

Model Number	ROTAREX®S 6F 135CM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Stenosis (2263); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect device not returned yet.The return of suspect device is expected.
Event or Problem 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.
Additional Manufacturer Narrative
Device was discarded at the hospital.Investigation was performed without the device.

• Brand Name: ROTAREXS 6F 135CM (STRAUB MEDICAL)
• Common Device Name: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10791987
• Report Number: 3008439199-2020-00054
• Device Sequence Number: 2549163
• Product Code: MCW
• UDI-Device Identifier: 07640142810261
• UDI-Public: 7640142810261
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K172315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention