MAUDE Adverse Event Report: UNKNOWN ASPIREX; THROMBECTOMY & ATHERECTOMY

Model Number	80203
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
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 not provided, a review of the device history records could not be 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 a recanalization procedure, the guidewire allegedly stuck on the catheter.It was further reported that there was allegedly shards of the device in the saline.There was no reported patient injury.
Additional Manufacturer Narrative
H10: additional information was received and the file was reassessed for reportability and determined to be reportable as serious injury.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 physical sample was returned for evaluation.A catheter was physically investigated.The catheter was blocked due to unknown reason.Full aspiration could be achieved after flushing.Residuals of tissue were seen on the guidewire.No malfunction of the catheter detected.The leakage reported by the user can not be confirmed.No leakage was detected between the catheter handle and shaft or at any other part of the catheter.A definitive root cause could not be determined based upon the available information.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: d4 (expiry date: 04/2025).H11: b5, d4 (medical device lot), h1, h6 (patient, method, result, conclusion).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
It was reported that during a recanalization procedure, the guidewire allegedly stuck on the catheter.It was further reported that there was allegedly shards of the device in the saline.Reportedly, the distal posterior tibial vessel was damaged and a sheath was used to cover and stop the bleeding.Additional medication was provided for pain, vein damage and hematoma.The procedure was completed using another device.The current status of the patient was unknown.

• 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: 15526657
• Report Number: 3008439199-2022-00145
• Device Sequence Number: 2506737
• Product Code: DQX
• UDI-Device Identifier: 07640142810438
• UDI-Public: (01)07640142810438
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/27/2022

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: 80203
• Device Catalogue Number: 80203
• Device Lot Number: 220649
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 11/21/2022
• 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: Male
• Patient Race: White