MAUDE Adverse Event Report: UNKNOWN ASPIREX; THROMBECTOMY & ATHERECTOMY

Model Number	80325
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a recanalization procedure in a radial cephalic fistula via cephalic vein retrograde access, the unit was allegedly clutched out.It was further reported that when the device was removed for flushing the unit over the wire, the device allegedly threw the wire upon flushing.Reportedly, the wire allegedly ripped the vein and perforated it.The procedure was completed by placing a permcath.The current status of the patient was unknown.
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 return of the sample is pending.However, a photo and an image were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2024).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 pending return.
Event or Problem Description
It was reported that during a recanalization procedure in a radial cephalic fistula via cephalic vein retrograde access, the unit was allegedly clutched out.It was further reported that when the device was removed for flushing the unit over the wire, the device allegedly threw the wire upon flushing.Reportedly, the wire allegedly ripped the vein and perforated it.The procedure was completed by placing a permcath.The current status of the patient was unknown.
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 catheter was physically investigated.The coiled tip of the guidewire was slightly deformed.There was a strong kink of the tube noted at 66.5 cm from the tip of the catheter.It was possible to pass the guidewire without strong resistance.After flushing and running in the water nominal aspiration level was achieved.It is assumed there was a mechanical jam that led to guidewire deformation and kink of the tube.The test guidewire still did not pass all the way through the catheter due to mechanical jam.Therefore, the investigation is unconfirmed for the reported guidewire break 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.H10: (expiration date: 08/2024).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.

• 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: 17254688
• Report Number: 3008439199-2023-00112
• Device Sequence Number: 20348172
• Product Code: DQX
• UDI-Device Identifier: 07640142811329
• UDI-Public: (01)07640142811329
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 09/20/2023

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 Model Number: 80325
• Device Catalogue Number: 80325
• Device Lot Number: 220994
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 10/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White