MAUDE Adverse Event Report: Straub Medical AG Rotarex; Thrombectomy & Atherectomy

Catalog Number	80236
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a thrombectomy and atherectomy procedure using a rotarex device for the treatment of superficial femoral artery (sfa) and popliteal artery disease.During the procedure, it was reported that the guidewire fractured was noticed to be broken off, resulting in retention of a wire fragment within the patient.A covered stent was subsequently implanted to entrap the retained fragment.The patient's current condition was reported as good.
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 / images / videos were received.A physical investigation was not possible.Due to no sample / images / videos received, the reported malfunction cannot be confirmed.A possible reason for the breakage of the guide wire could be insufficient drainage flow through the catheter which leads to heat development inside the catheter, or as it is stated in the report abnormal rapid move of the patient.The guidewire and helix tend to break easily when set under stress.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 labelling or use related issue, a labelling review is not required.D2b (mcw; dqx), e1, g3, h6 (component).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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50144049
• Report Number: 3008439199-2026-00261
• Device Sequence Number: 15756051
• Product Code: MCW
• UDI-Device Identifier: 07640142811855
• UDI-Public: (01)07640142811855(17)280130(10)250611
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 80236
• Device Lot Number: 250611
• 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: 07/06/2026
• Supplement Date Received by Manufacturer: 08/08/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/01/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown