MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER SELECT; CATHETER, CONTINUOUS FLUSH

Catalog Number	606S155FX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Information regarding patient height and medical history was not reported.The device was not returned for analysis; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31411524 number, and no non-conformance's related to the malfunction were identified.A separated tip could embolize, with the potential for ischemia or infarct.With the limited information provided, possible causes or contributing factors for this event are unknown; however, there are clinical and procedural factors, including vessel characteristics, tortuosity, device selection, and mechanical manipulation of devices within the artery, that may have contributed to the reported event rather than the design or manufacture of the device.The original procedure plans were modified based on a separated microcatheter tip retained in the left common carotid artery; a stabilizing device, such as a stent, may have been required to anchor the fragment to the vessel, avoiding possible migration.Additionally, the patient may be required to take additional anticoagulation medications to avoid thrombus formation.The details of the procedure are unknown.Therefore, this event will be conservatively reported to the us fda, reporting under criteria 21 cfr 803 with the classification of ¿serious injury,¿ with an awareness date of 10-mar-2025.The file will be re-reviewed if additional information is received at a later date.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.
Event or Problem Description
It was reported, via a health authority report, that a prowler select lpes 45 deg tip microcatheter (606s155fx/ 31411524) was used for a neurointerventional transcatheter embolization.During the procedure, the user reported the distal tip of the catheter separated while in patient.The fragment was left in patient, as the physician was unable to safely remove it.No further details were provided.The event was reported as such, ¿while undergoing a neurointerventional transcatheter embolization on (b)(6) 2024 the catheter tip fractured in the left common carotid artery.The catheter tip fragment was retained as the provider was unable to safely remove it and the risk outweighed the benefit of doing so.¿.

• Brand Name: PROWLER SELECT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 21740831
• Report Number: 3008114965-2025-00275
• Device Sequence Number: 12920460
• Product Code: KRA
• UDI-Device Identifier: 10886704028772
• UDI-Public: (01)10886704028772(17)270630(10)31411524
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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 Catalogue Number: 606S155FX
• Device Lot Number: 31411524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White