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

Catalog Number	80237
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
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 will be performed.The return of the sample is pending however; photos were provided for review.The investigation of the reported event is currently underway.D2b (mcw; dqx).Section a through f - the information provided by bd represents all of 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) 2025, a patient underwent a recanalization procedure using rotarex device.During the procedure, device passed through without clutching, the helix was allegedly found to be broken inside the patient upon removing.Able to snare and remove the remaining piece without harm to the patient.Removed the device completed angioplasty, had a good result.
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 was returned for evaluation and a physical investigation was performed on the catheter.During physical investigation a catheter with a broken helix and the collecting bag attached to it were received.The helix was found broken at 20 cm from the tip of the catheter.The collecting bag tube had no issues.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), g3, h6 (component, method, result, conclusion).Section a through f - the information provided by bd represents all of 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) 2025, a patient underwent a recanalization procedure using rotarex device.During the procedure, device passed through without clutching, the helix was allegedly found to be broken inside the patient upon removing.Able to snare and remove the remaining piece without harm to the patient.Removed the device completed angioplasty, had a good result.There was no reported patient injury.

• 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: 22826154
• Report Number: 3008439199-2025-00187
• Device Sequence Number: 9336655
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: (01)07640142810582(17)280221(10)250844
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 80237
• Device Lot Number: 250844
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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