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

Catalog Number	80233
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/23/2025
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.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) 2025, an 88-year-old patient underwent a thrombectomy and atherectomy procedure using an aspirex device.During the procedure, it was noticed that the guide provided in the kit was broken.It was retrieved by lasso.The current status of the patient is unknown.
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: the physical sample was returned for evaluation, and a catheter was physically investigated.During physical investigation, a guide wire was received.The guide wire was found broken at 27 cm from the tip of the guide wire and a strong kink at golden tip of the guide wire was observed.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 labeling or use related issue, a labeling review is not required.G3, h6 (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
On (b)(6) 2025, an 88 year old patient underwent a thrombectomy and atherectomy procedure using an aspirex device.During the procedure, it was noticed that the guide provided in the kit was broken.It was retrieved by lasso.The current status of the patient is unknown.

• Brand Name: ROTAREX & ASPIREX ACCESSORIES
• 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: 24159899
• Report Number: 3008439199-2025-00345
• Device Sequence Number: 9020098
• Product Code: DQX
• UDI-Device Identifier: 07640142810247
• UDI-Public: (01)07640142810247(10)92101370
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K211738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 80233
• Device Lot Number: 92101370
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/10/2026
• 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 Age: 88 YR
• Patient Sex: Unknown