MAUDE Adverse Event Report: MICROVENTION, INC. ERIC RETRIEVAL DEVICE; CATHETER, THROMBUS RETRIEVER

Model Number	ER176044-US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a patient was being treated for an acute stroke.The eric device was prepped in usual fashion and tracked through the microcatheter to the location of the clot.A 6f sofia 131 was used in conjunction for aspiration and delivery.Device was used for one pass, then removed and cleaned on the back table.When reintroduced into the patient for a second pass it was alleged by the physician, that under fluoro, the radiopaque lead wire tip was missing from the eric device.The eric device, microcatheter, and sofia were removed from the patient without incident.It was then confirmed under fluoro that the tip was not in the patient.It also was not located in the microcatheter or in the sofia.A new eric 6 device was opened and used two times in the patient.This second device successfully removed the clot after 2 passes.Case was completed without further incident.The sales rep was not present at the case.It was later reported the following day, it was alleged that the missing lead wire tip from the eric 6 device was visualized on a head ct within an intracranial vessel and in the same territory as the patient¿s original acute stroke.The physician reported that the physician believes it to be the tantalum wind from around the distal tip of the eric, as the damaged device that was removed still has a distal lead wire intact.The patient¿s neurological status remains unchanged at this point and that the patient has no injury and is at baseline neuro status.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation; however, it has not yet been returned despite attempts made.Additional due diligence attempts are ongoing.An image was received for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
One radiographic image was provided for review.It shows a short, linear metallic density in an area presumed to be a distal branch of the right mca, visually consistent with the fragment described in the reported event.The investigation found the eric returned with the distal coil missing, which is consistent with the alleged product issue.The monofilament was still attached but broken at the distal end, and the distal laser weld appeared intact.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the broken distal coil and monofilament, but the damage is consistent with the device experiencing forces exceeding its tensile strength.The distal coil likely broke while the device was being cleaned after the first pass; however, it remained attached via the monofilament, which subsequently broke during the second pass.The catheters used in the procedure were not returned, so the investigation could not determine if they had caused or contributed to the reported event.A search for non-conformance's associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.
Event or Problem Description
No new information was received.

• Brand Name: ERIC RETRIEVAL DEVICE
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; allso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 23490940
• Report Number: 2032493-2025-90633
• Device Sequence Number: 20988899
• Product Code: NRY
• UDI-Device Identifier: 00810170018862
• UDI-Public: (01)00810170018862(11)241003(17)270930(10)0000718849
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K211120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2026

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: ER176044-US
• Device Catalogue Number: ERIC176044
• Device Lot Number: 0000718849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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: HEADWAY 21.; SOFIA 131 6F.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male