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

Catalog Number	80237
Medical Device Problem Codes	Break (1069); Noise, Audible (3273)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient underwent a thrombectomy and atherectomy procedure using a rotarex device for superficial femoral artery (sfa) occlusion.Reportedly, the helix fractured while the rotarex device was operating inside the patient.The entire fractured portion was successfully retrieved by intertwining a 0.014 inch guidewire with the distal portion of the helix and withdrawing it through the sheath using the same access site.The retrieval process was reported to be complicated, challenging, and time consuming.The current condition of the patient is unknown.
Event or Problem Description
On (b)(6)2026, a patient underwent a thrombectomy and atherectomy procedure using a rotarex device for the treatment of a superficial femoral artery (sfa) occlusion.During the procedure, while the catheter was traversing approximately 75 percent of the occlusion, an abnormal audible noise was noted.The catheter was subsequently withdrawn, and inspection revealed that the internal helix had fractured.It was further reported that the catheter tip and a portion of the fractured helix remained within the patient.Retrieval of the retained fragment was successfully performed by intertwining a 0.014-inch guidewire with the distal portion of the fractured helix and withdrawing it through the sheath via the original access site.An attempted retrieval using a snare technique was unsuccessful.The retrieval process was reported to be prolonged and technically challenging.Following successful fragment retrieval, the procedure was completed with placement of three stents in the sfa.The patient's current status is unknown.
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.
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: the physical sample was returned for evaluation and a catheter was received and physically investigated.During physical investigation, the helix was found broken at 46.5 cm from the tip of the catheter.A clear root cause could not be identified but a damaged catheter 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.E1 ((b)(6) ).H.4.Device manufacture date: unknown.B5, 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50322796
• Report Number: 3008439199-2026-00285
• Device Sequence Number: 18596382
• Product Code: MCW
• UDI-Device Identifier: 07640142811862
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/23/2026

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: 08/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/23/2026
• 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