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	08/27/2026
Type of Reportable Event	Malfunction

• 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: 50736667
• Report Number: 3008114965-2026-01175
• Device Sequence Number: 10662096
• Product Code: QJP
• UDI-Device Identifier: 10886704028888
• UDI-Public: (01)10886704028888(17)271031(10)31527352
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 09/11/2026

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: 31527352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2024
• 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
• Patient Sex: Unknown