MAUDE Adverse Event Report: STRAUB MEDICAL AG Rotarex; Thrombectomy & Atherectomy

Catalog Number	80237
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
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 a rotarex device.During the procedure, it was reported that the guidewire fused with the catheter and the helix broke.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2026, a patient underwent a thrombectomy and atherectomy procedure using a rotarex device via femoral access.During the procedure, it was reported that the guidewire fused with the catheter and the helix broke.Additionally, a small perforation occurred in the superficial femoral artery (sfa) just distal to the common femoral artery.To treat the perforation, a covered stent was implanted.The access site was femoral.Currently, the patient is well.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review for the catheter was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: catheter and guidewire and the collecting bag were 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 were received.The golden tip of the guide wire was found worn out.The collecting bag connector had no issues.Due to the clogging with bodily material flushing was necessary, even after flushing it was not possible to aspirate the catheter.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), b1, b5, 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25824107
• Report Number: 3008439199-2026-00250
• Device Sequence Number: 9721463
• Product Code: MCW
• UDI-Device Identifier: 07640142811862
• UDI-Public: (01)07640142811862(17)281215(10)260510
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/29/2026

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: 80237
• Device Lot Number: 260510
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 10/01/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown