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

Catalog Number	80238
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
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
A patient underwent a thrombectomy and atherectomy procedure using a rotarex device.During the procedure, the catheter was placed on the field, but upon inspection, the end of the device was found to be bent, preventing insertion of the wire.The procedure was completed using another device.There was no reported patient contact.
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 physically investigated.During physical investigation, a catheter was received.The guide wire adaptor was observed to be deformed.The test guide wire went through the catheter without any resistance.The aspiration test was performed, and nominal aspiration level was achieved.A deformation can have various reasons.A clear root cause could not be established.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D2b (mcw; dqx), e1, g3, h6 (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
A patient underwent a thrombectomy and atherectomy procedure using a rotarex device.During the procedure, the catheter was placed on the field, but upon inspection, the end of the device was found to be bent, preventing insertion of the wire.The procedure was completed using another device.There was no patient contact.

• 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: 24556100
• Report Number: 3008439199-2026-00051
• Device Sequence Number: 9467073
• Product Code: MCW
• UDI-Device Identifier: 07640142811879
• UDI-Public: (01)07640142811879(17)260930(10)241330
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/23/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 80238
• Device Lot Number: 241330
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White