MAUDE Adverse Event Report: UNKNOWN ASPIREX; THROMBECTOMY & ATHERECTOMY

Model Number	80204
Medical Device Problem Codes	Retraction Problem (1536); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medical device manufacturer and manufacturing location for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.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.
Event or Problem Description
It was reported that during recanalization procedure via popliteal access for a patient diagnosed with deep vein thrombosis, the device wire allegedly could not be removed from the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: 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 sample was returned for evaluation.A physical investigation was performed for the catheter.The catheter was blocked due to a high amount of blood and coagulation material in the catheter.After flushing, rotation could still not be reestablished.Due to the results, mechanical jam can be confirmed as a root cause of device malfunction.Therefore, the investigation is confirmed for the reported issue.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f ¿ the information provided 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
It was reported that during recanalization procedure via popliteal access for a patient diagnosed with deep vein thrombosis, the device wire allegedly could not be removed from the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: d4 (medical device lot number), h6 (method).H11: section a through f the information provided 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
It was reported that during recanalization procedure via popliteal access for a patient diagnosed with deep vein thrombosis, the device wire allegedly could not be removed from the catheter.There was no reported patient injury.

• Brand Name: ASPIREX
• Common Device Name: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): UNKNOWN; BR
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16451560
• Report Number: 3008439199-2023-00020
• Device Sequence Number: 5599888
• Product Code: DQX
• UDI-Device Identifier: 07640142810483
• UDI-Public: (01)07640142810483
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 06/06/2023

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 Model Number: 80204
• Device Catalogue Number: 80204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 04/21/2023; 06/06/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/16/2023; 06/09/2023
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: Black Or African American