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	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, the 4mm x 23mm enterprise 2 (encr402312 / 10071618) was impeded in the distal end of the associated 150cm x 5cm prowler select plus microcatheter (606s255x / 31877599) and could not pass through the microcatheter.The physician removed the stent, which was still inside the microcatheter, and the microcatheter from the patient and replaced both devices with devices from different manufacturers to complete the procedure.There was no report of any negative patient impact.On (b)(6) 2026, additional information was received.Per the information, the procedure was targeting the middle cerebral artery (mca).The information indicated that there was resistance during the advancement of the stent; the stent was impeded in the distal end of the microcatheter during the procedure.Continuous flush was maintained through the microcatheter.The flush was heparinized saline.There was no damage noted on the microcatheter.There was no negative patient impact and no delay to the procedure.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Section h.3: 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.A review of manufacturing documentation associated with this lot (31877599) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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: 50487258
• Report Number: 3008114965-2026-01126
• Device Sequence Number: 16033204
• Product Code: QJP
• UDI-Device Identifier: 10886704028888
• UDI-Public: (01)10886704028888(17)290131(10)31877599
• 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): 08/27/2026

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: 31877599
• 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: 08/17/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2026
• 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