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

Catalog Number	80326
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Jam (2983)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: 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.H3 other text : device not returned.
Event or Problem Description
It was reported that during a thrombectomy and atherectomy procedure in the left upper arm clotted fistula via the upper arm cephalic vein approach, the system allegedly clutched out and made a loud noise while began to work.It was further reported that when the catheter was removed and flushed, a fibrous piece of tissue was allegedly found to be adhered to the tip of the catheter.Furthermore, the catheter was passed again for a few times through the fistula, and it was found that the upper arm cephalic vein was allegedly torn.Reportedly, a covered stent graft was placed to seal the tear and cover the leak in the vein.The patient¿s access was saved and was reported to be stable now.

• 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: 19256803
• Report Number: 3008439199-2024-00079
• Device Sequence Number: 12385214
• Product Code: DQX
• UDI-Device Identifier: 07640142811336
• UDI-Public: (01)07640142811336
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K220270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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: 80326
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown