MAUDE Adverse Event Report: Medos International SARL PROWLER SELECT; Catheter, Percutaneous, Neurovasculature

Catalog Number	606S255X
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during an endovascular embolization, when delivering a 4.5mmd 22mml enterprise vascular reconstruction device (product code: enc452200, lot number: 9682206), the stent became impeded in the distal end of a prowler select plus 150/5cm microcatheter (product code: 606s255x, lot number: 31874892) and could not pass through the microcatheter (mc).The doctor removed the stent and microcatheter from the patient and then sequentially switched to a second microcatheter, a prowler select plus 150/5cm (product code: 606s255x, lot number: 31519699) to deliver the original stent.The original stent was still impeded in the distal end of the second and third microcatheter and could not pass through the second and the third microcatheter.Finally, the doctor only retracted the original stent alone and switched to a second stent to complete the surgery.The third microcatheter was not replaced.The surgery was prolonged by about 15 minutes.Does surgeon have an extra set of hands to support while flushing aligning the enterprise system was answered as ¿yes¿.Is a push plunge rhv being used was answered as ¿twisted type¿.Is there force needed to remove the delivery wire once impeded and then the stent detaches in the hub or the proximal end of the microcatheter was answered as ¿no, the delivery wire was removed smoothly, and the stent was still attached to the delivery wire¿.The replacement stent was another enterprise1 of a different product code.Additional event information received on 19-aug-2026 indicated that a guidewire in the microcatheter was used prior to using the enterprise system.A saline flush was used during the procedure.They were able to torque the device (s).There was no evidence of physical material within the device.The microcatheters did not kink/bent.The 15 minutes procedural delay did not result in a patient adverse consequence.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6) section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PROWLER SELECT
• Common Device Name: Catheter, Percutaneous, Neurovasculature
• Manufacturer (Section D): Medos International SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): Cerenovus Inc. (Juarez); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50524645
• Report Number: 3008114965-2026-01161
• Device Sequence Number: 6012465
• Product Code: QJP
• UDI-Device Identifier: 10886704028888
• UDI-Public: (01)10886704028888(17)290131(10)31874892
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 606S255X
• Device Lot Number: 31874892
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2026
• 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
• Patient Sex: Unknown