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

Catalog Number	80328
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H11: d2b (qew; dqx).H11: 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 a recanalization procedure using the aspirex catheter.During the procedure in the popliteal vein via ipsilateral approach, the large amount of blood coming out the back of the green handle.There was no reported patient injury.
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: catheter was returned for evaluation, and a physical investigation was performed on the catheter.During physical investigation a heavy clogged catheter was received.The test guide wire went through the catheter with slight resistance.The aspiration test was performed, and nominal aspiration level was achieved.Therefore, the result of the investigation is not confirmed for the reported failure.A clear root cause could not be identified but a blockage of the 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.B5, d2b (qew; dqx), g3, h6 (device, 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 a recanalization procedure using the aspirex catheter in popliteal vein via ipsilateral.During the procedure, the large amount of blood coming out the back of the green handle.A 6fr aspirex was used after and stent was later placed.There was 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: 22165268
• Report Number: 3008439199-2025-00125
• Device Sequence Number: 9218614
• Product Code: QEW
• UDI-Device Identifier: 07640142811350
• UDI-Public: (01)07640142811350(17)270411(10)241189
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K220270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 80328
• Device Lot Number: 241189
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/06/2025
• 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