MAUDE Adverse Event Report: SCIENTIA VASCULAR SOCRATES 38 ASPIRATION CATHETER

Model Number	SOCRATES 038
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
From the review of the manufacturing lot history record, there is no indication that the break occurred due to a manufacturing defect and the lot met the releasing criteria.No manufacturing related issues were found during the investigation of this complaint.The event occurred during a stroke procedure utilizing a stent retriever.The current socrates 38 aspiration catheter ifu labeling warns against the foreseeable misuse of a stent retriever with the aspiration catheter.Breakage of the socrates 38 aspiration catheter was confirmed.The investigation results suggest the break occurred during removal due to a damaged guide catheter.The failure occurred from the damaged guide catheter by applying excessive force on the outer surface of the aspiration catheter.
Event or Problem Description
On 03 sep 2024, scientia vascular was notified that a socrates 38 (sc038-127-001, ln: 029278) aspiration catheter distal tip detached during a stroke procedure.The break occurred when the doctor was pulling the socrates 038 aspiration catheter into the cerebase guide catheter.The broken piece of the socrates 038 remained in the patient supported by a stent.The event was initially described as follows: "during a stroke the soc 127 / headway duo 167 / tiger 13 was advanced.Tiger 13 was deployed then constrained 50% and pulled back.It was then constrained another 25% to fit into the guide.While pulling everything back into the guide the tip of the soc127 detached and went distal.The doctor tried to retrieve it but could not.He ended up stetting over it." the complaint unit (socrates 038) was returned to scientia vascular on 10-sep-2024.

• Brand Name: SOCRATES 38 ASPIRATION CATHETER
• Common Device Name: ASPIRATION CATHETER
• Manufacturer (Section D): SCIENTIA VASCULAR; 2460 south 3270 west; west valley city UT 84119
• Manufacturer (Section G): SCIENTIA VASCULAR; 2460 south 3270 west; west valley city UT 84119
• Manufacturer Contact: raquel johnson ; 2460 south 3270 west; west valley city, UT 84119
• MDR Report Key: 20362704
• Report Number: 3009546466-2024-00012
• Device Sequence Number: 18176746
• Product Code: NRY
• UDI-Device Identifier: 00818075011025
• UDI-Public: (01)00818075011025(17)250630(10)029278
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K223913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

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 Expiration Date: 06/30/2025
• Device Model Number: SOCRATES 038
• Device Catalogue Number: SC038-127-001
• Device Lot Number: 029278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATLAS STENT; CEREBASE DA GUIDE SHEATH; HEADWAY DUO 167; TIGERTRIEVER 13
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown