MAUDE Adverse Event Report: UNKNOWN ASPIREX GUIDEWIRE 0.025 6/270CM ANGLED; THROMBECTOMY & ATHERECTOMY

Catalog Number 80265

Device Problems Peeled/Delaminated (1454); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2023

Event Type  malfunction  

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 not returned for evaluation.A physical investigation was not possible.The user report contains information regarding failure to advance.Photos were provided for review.One of the pictures as focused wrong and nothing could be seen.The other picture showed a bit coating off on the guidewire.The reported in the images damage/ coating peel of the guidewire would not cause failure to advice.Most probable cause was mechanical jam of the catheter that resulted in guidewire damage.A clear root cause could not be identified but a damaged 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.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.H3 other text : device not returned.

Event Description

It was reported that during a recanalization procedure, the device allegedly failed to advance.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ASPIREX GUIDEWIRE 0.025 6/270CM ANGLED
• Type of Device: 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: 17471219
• MDR Text Key: 320524191
• Report Number: 3008439199-2023-00126
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 07640142810735
• UDI-Public: (01)07640142810735
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80265
• Device Lot Number: 92101367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1