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

Model Number SET ROTAREX®S 6F X 110CM

Device Problems Break (1069); Fracture (1260)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation protocol not completed yet.

Event 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intimal hyperplasia).Device kept running, but saw the tip wasn't spinning.Broken helix came out of catheter when being withdrawn from ansel sheath.100mm length broke.Hi flex cook ansel sheath.Run time about 8 seconds.

Manufacturer Narrative

Summary evaluation report attached.

• Brand Name: ROTAREXS 6F 110CM (STRAUB MEDICAL)
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10792735
• MDR Text Key: 216414348
• Report Number: 3008439199-2020-00056
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810575
• UDI-Public: 7640142810575
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1