MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 110CM (STRAUB MEDICAL); ATHERECTOMY CATHETER

Model Number	SET ROTAREX®S 6F X 110CM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation protocol not completed yet.
Event or Problem Description
Anastomotic lesion in bypass graft, proximal location.Up and over, not a steep bifurcation.Rotarex clutched out (no calcification in graft, purely intimal hyperplasia).Device kept running, but saw the tip wasn't spinning.Broken helix came out of catheter when being withdrawn from ansel sheath.100mm length broke.Hi flex cook ansel sheath.Run time about 8 seconds.
Additional Manufacturer Narrative
Summary evaluation report attached.

• Brand Name: ROTAREXS 6F 110CM (STRAUB MEDICAL)
• Common Device Name: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10792735
• Report Number: 3008439199-2020-00056
• Device Sequence Number: 3732805
• Product Code: MCW
• UDI-Device Identifier: 07640142810575
• UDI-Public: 7640142810575
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: 05/26/2023
• Device Model Number: SET ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80236
• Device Lot Number: 200704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1