MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER-14 DUAL MARKER; CATHETER, CONTINUOUS FLUSH

Catalog Number	606151X
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, an embolic coil (unspecified brand) was impeded in the 150cm prowler14 dual markers microcatheter (606151x / 31130286) and could not advance and could not pass through the microcatheter.The physician removed the microcatheter and the coil from the patient and switched to a new microcatheter to complete the procedure using the original embolic coil.There was no report of any negative patient impact.On 30-may-2024, additional information was received.Per the information, the procedure was targeting the right internal carotid artery / posterior communicating artery.The vessel was ¿more tortuous.¿ it was indicated that resistance was first felt during the re-sheathing of the device for re-use; it was felt inside the microcatheter at the distal section.Continuous flush was maintained through the microcatheter.Nothing was noted to be obstructing the microcatheter.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during advancement.The information indicated that the microcatheter was damaged during device manipulation, pushing the second coil and resistance was felt at the distal end of the microcatheter.Based on the additional information received on 30-may-2024, the event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: (b)(6).The initial reporter email address was not available / reported.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 150cm prowler14 dual markers microcatheter was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.The inner diameter (id) and outer diameter (od) were confirmed to be within specifications.An attempt to flush the microcatheter but it was found to be obstructed and a strong resistance was felt between the lab sample guidewire and the microcatheter at 22 cm from the proximal end of the microcatheter.The microcatheter was then dissected, and it was confirmed to be obstructed by dried blood residues.The issue reported regarding the microcatheter being obstructed was confirmed due to the findings documented above.The residues found inside the microcatheter suggest that an adequate flush was not maintained.According to the risk documentation, a continuous flush not maintained is a potential failure mode that can cause air in system or stagnant blood.Also, insufficient flushing is a potential failure mode that can compromise the performance of the therapeutic device.With the information available and the evidence obtained from the returned device, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (31130286) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages from leaving the facility.It should be noted that product failure is multifactorial.The instructions for use (ifu) provides the following recommendations: ¿ the catheter may be hydrated in the tray prior to use.¿ do not attempt to use infusion catheters without flushing first to hydrate the coating.Failure to do so may compromise the coating and lubricity of the catheter.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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 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-14 DUAL MARKER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 19590262
• Report Number: 3008114965-2024-00635
• Device Sequence Number: 3505639
• Product Code: KRA
• UDI-Device Identifier: 10886704028628
• UDI-Public: 10886704028628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 06/21/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 606151X
• Device Lot Number: 31130286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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: EMBOLIC COIL (UNSPECIFIED BRAND)
• Patient Sex: Female