MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number	80201
Medical Device Problem Codes	Retraction Problem (1536); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.Section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2025, a 60-year-old male patient underwent percutaneous femoral artery thrombectomy and endovascular angioplasty for ulceration of the second toe of the right foot for more than a month using a rotarex 6f 135cm catheter.During the procedure, the catheter suctioned from the superficial femoral artery to the femoral popliteal artery three times, and the body of the tubing was found to be bent, and the device was difficult to remove.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: no physical sample was received.A physical investigation was not possible.The user report and provided image contains information regarding catheter kinked catheter.After review of the provided images kinked catheter can be confirmed.A clear root cause could not be identified but a damaged guidewire represents a known inherent risk.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G2, g3, h6 (device, component, method, result, conclusion).Section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2025, a 60-year-old male patient underwent percutaneous femoral artery thrombectomy and endovascular angioplasty for ulceration of the second toe of the right foot for more than a month using a rotarex 6f 135cm catheter.During the procedure, the catheter suctioned from the superficial femoral artery to the femoral popliteal artery three times, and the body of the tubing was found to be bent, and the device was difficult to remove.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: ROTAREX
• Common Device Name: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; ch-7323; wangs SG 73 23; SZ SG 7323
• Manufacturer (Section G): STRAUB MEDICAL AG; straubstrasse 12; ch-7323; wangs SG 73 23; SZ SG 7323
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22313391
• Report Number: 3008439199-2025-00139
• Device Sequence Number: 8857868
• Product Code: MCW
• UDI-Device Identifier: 07640142810292
• UDI-Public: (01)07640142810292
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K211738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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 Catalogue Number: 80201
• Device Lot Number: 242410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male