MAUDE Adverse Event Report: UNKNOWN ASPIREX GUIDEWIRE 0.018 4/270CM ANGLED; THROMBECTOMY & ATHERECTOMY

Model Number	VERSION 1.0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a recanalization procedure through left iliac femoral vein, the guidewire allegedly broken.It was further reported that the fragments are inside the patient's blood vessel.The current status of the patient is unknown.
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 (b)(4) 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.(expiration date: 05/2024).
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 not returned for evaluation.Images were provided.All images show delamination of the guidewire coating and decoiled tip of the guidewire.Decoiling of the guidewire can occur during heavy blockage of the catheter when the guidewire start to move with the inner helix.The break of the guidewire can be result of blockage or aspiration of very thick thrombotic material that results in catheter overheating, moving together with the guidewire, guidewire overheating and break.Based on the images it can be confirmed that guidewire was broken.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: 05/2024), g3, h6 (method) h11: h6 (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.H3 other text : device not returned.
Event or Problem Description
It was reported that during a recanalization procedure through left iliac femoral vein, the guidewire allegedly broken.It was further reported that the fragments are inside the patient's blood vessel.The current status of the patient is unknown.

• Brand Name: ASPIREX GUIDEWIRE 0.018 4/270CM ANGLED
• 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: 15822580
• Report Number: 3008439199-2022-00165
• Device Sequence Number: 6143321
• Product Code: DQX
• UDI-Device Identifier: 07640142810254
• UDI-Public: (01)07640142810254
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2022

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: VERSION 1.0
• Device Catalogue Number: 80234
• Device Lot Number: 91807783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 37 YR
• Patient Sex: Female