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

Catalog Number	80239
Medical Device Problem Codes	Leak/Splash (1354); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
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.The investigation of the reported event is currently underway.D2b: (mcw; dqx).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) 2026, a patient underwent a thrombectomy and atherectomy procedure using the rotarex device.During the procedure, it was reported that the blood was noted to be leaking from the metal portion of the catheter located above the handle.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2026, a patient underwent a thrombectomy and atherectomy procedure using the rotarex device.During the procedure, it was reported that the blood was noted to be leaking from the metal portion of the catheter located above the handle.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: catheter was returned for evaluation, and a physical investigation was performed on the catheter.During physical investigation a catheter, the guide wire stuck inside, and the collecting bag attached to the device were received.The catheter was found heavily clogged with bodily material.The tube had a strong kink / hole under the kink protection.The aspiration test was performed and lower aspiration level than nominal was achieved.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D2b (mcw; dqx), 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.

• 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: 24492919
• Report Number: 3008439199-2026-00046
• Device Sequence Number: 4953873
• Product Code: MCW
• UDI-Device Identifier: 07640142811886
• UDI-Public: (01)07640142811886(17)261019(10)231883
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K211738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 80239
• Device Lot Number: 231883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown