MAUDE Adverse Event Report: STRAUB MEDICAL AG ASPIREX; THROMBECTOMY & ATHERECTOMY

Catalog Number	80203
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Extravasation (1842); Vascular Dissection (3160)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thrombectomy and atherectomy procedure in the left upper arm fistula via the left arm cephalic vein, the catheter allegedly encountered resistance in the vein and when attempted to remove it from the patient, the wire was unable to be kept in place as the catheter allegedly prevented the wire from being advanced or pulled back.It was further reported that the catheter was removed with the wire allegedly being stuck inside of it, losing wire access.Furthermore, under a venogram, it was found that there was extravasation and dissection of the vessel where the catheter was operated.Reportedly, compression was done for extravasation and tissue plasminogen activator was initially used to open the fistula but the fistula failed to achieve the patency and was lost.The current status of the patient was unknown.
Additional Manufacturer Narrative
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.The investigation of the reported event is currently underway.H10: d4 (expiration date: 10/2025).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.H3 other text: device pending return.
Additional Manufacturer Narrative
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 not returned for evaluation and a physical investigation was not possible.No images or videos were provided for review.The user reported guidewire getting stuck inside of the catheter, due to no sample reported mechanical jam/blocked catheter cannot be confirmed.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 10/2025), g3, h6 (method) h11: h6 (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.
Event or Problem Description
It was reported that during a thrombectomy and atherectomy procedure in the left upper arm fistula via the left arm cephalic vein, the catheter allegedly encountered resistance in the vein and when attempted to remove it from the patient, the wire was unable to be kept in place as the catheter allegedly prevented the wire from being advanced or pulled back.It was further reported that the catheter was removed with the wire allegedly being stuck inside of it, losing wire access.Furthermore, under a venogram, it was found that there was extravasation and dissection of the vessel where the catheter was operated.Reportedly, compression was done for extravasation and tissue plasminogen activator was initially used to open the fistula, but the fistula failed to achieve the patency and was lost.The current status of the patient was unknown.

• Brand Name: ASPIREX
• Common Device Name: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; ch-7323; wangs SG 73 23; SZ SG 7323
• Manufacturer (Section G): STRAUB MEDICAL AG; straubstrasse 12; ch-7323; wangs SG 73 23; SZ SG 7323
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19247122
• Report Number: 3008439199-2024-00078
• Device Sequence Number: 6438362
• Product Code: DQX
• UDI-Device Identifier: 07640142810438
• UDI-Public: (01)07640142810438
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/11/2024

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 Catalogue Number: 80203
• Device Lot Number: 221791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 07/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown