MAUDE Adverse Event Report: UNKNOWN ASPIREX; THROMBECTOMY & ATHERECTOMY

Model Number	80327
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a recanalization procedure, upon the start of operation in the body the catheter allegedly would not move back on the wire.It was further reported that upon fluoroscopic examination it was observed that there was a well over ten centimeters of wire protruded out of the tip of the catheter.Furthermore, the physician attempted to remove the catheter over the wire and out the sheath and it did not move.Reportedly, after multiple attempts to remove the catheter over the wire failed and the procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
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.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, images were provided for review.The investigation of the reported event is currently underway.Device identification (expiry date: 08/2024).
Event or Problem Description
It was reported that during a recanalization procedure, upon the start of operation in the body the catheter allegedly would not move back on the wire.It was further reported that upon fluoroscopic examination it was observed that there was a well over ten centimeters of wire protruded out of the tip of the catheter.Furthermore, the physician attempted to remove the catheter over the wire and out the sheath, and it did not move.Reportedly after multiple attempts to remove the catheter over the wire failed and the procedure was completed using another device.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 physical device was returned for evaluation.A catheter and the guidewire were physically investigated.During physical investigation it was noted a lot of coagulated material inside of the catheter and test guidewire was not passing.The coiled tip of the guidewire was missing and blocking the helix right at the handle of the catheter.Therefore, the investigation is confirmed for the reported break issue.A clear root cause could not be identified but a broken guidewire 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: d4 (expiration date: 08/2024), g3, h6 (device).H11: h6 (method, result, conclusion).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: 16690691
• Report Number: 3008439199-2023-00048
• Device Sequence Number: 5930978
• Product Code: DQX
• UDI-Device Identifier: 07640142811343
• UDI-Public: (01)07640142811343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/26/2023

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: 80327
• Device Catalogue Number: 80327
• Device Lot Number: 220936
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/30/2023
• 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 Sex: Unknown