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

Catalog Number	80230
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Device Markings/Labelling Problem (2911); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: the catalog number identified in section d4 has not been cleared in the us but is similar to the aspirex that are cleared in the us.The pro code and 510 k number for the aspirex are identified in d2 and g4.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.However, photos were provided for review.The investigation of the reported event is currently underway.B5, d4 (medical device catalog #, medical device lot #), g2, g3, h6 (device, component, method).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 thrombectomy and atherectomy procedure using a aspirex device.During the procedure, allegedly the device produced unusual noise.Subsequent inspection revealed that the outer coil covering of the catheter shaft was stripped and damaged at that specific location.Reportedly, after the malfunction occurred, the catheter continued to rotate mechanically, but no aspiration was achieved.The procedure was successfully completed using argon cleaner + cqf to remove the thrombus.Also, it was further reported that the ref and lot numbers on the catheter package and the outer box were not identical.There is no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.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 thrombectomy and atherectomy procedure using a aspirex device.During the procedure, it was reported that the device had allegedly produced unusual noise.Subsequent inspection revealed that the outer coil covering of the catheter shaft was stripped and damaged at that specific location.Reportedly, after the malfunction occurred, the catheter continued to rotate mechanically, but no aspiration was achieved.The procedure was successfully completed using argon cleaner + cqf to remove the thrombus.There was no reported patient injury.
Additional Manufacturer Narrative
H11: the catalog number identified in section d4 has not been cleared in the us but is similar to the aspirex that are cleared in the us.The pro code and 510 k number for the aspirex are identified in d2 and g4.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: no physical sample was received.A physical investigation was not possible.The user report and the provided images contain information regarding catheter break / mechanical jam.After review of the provided images a kinked tube was observed.The reported failure about the mis-labeling can not be confirmed as the catheter itself does have another lot number and article number then the assembled catheter set.A clear root cause for these incidents could not be identified but the failure mode 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 (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.
Event or Problem Description
On (b)(6) 2025, a patient underwent thrombectomy and atherectomy procedure using a aspirex device.During the procedure, allegedly the device produced unusual noise.Subsequent inspection revealed that the outer coil covering of the catheter shaft was stripped and damaged at that specific location.Reportedly, after the malfunction occurred, the catheter continued to rotate mechanically, but no aspiration was achieved.The procedure was successfully completed using argon cleaner + cqf to remove the thrombus.Also, it was further reported that the ref and lot numbers on the catheter package and the outer box were not identical.There is no reported patient injury.

• Brand Name: ASPIREX
• 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: 23000865
• Report Number: 3008439199-2025-00208
• Device Sequence Number: 21104817
• Product Code: DQX
• UDI-Device Identifier: 07640142810483
• UDI-Public: (01)07640142810483
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K220270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: 80230
• Device Lot Number: 240285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 10/07/2025; 10/17/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/17/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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