MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER SELECT PLUS 150/5CM; CATHETER, CONTINUOUS FLUSH

Catalog Number 606S255X

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the 4mm x 30mm enterprise 2 stent (encr403012 / 7161626) was impeded in the proximal section of the 150cm x 5cm prowler select plus microcatheter (606s255x / 31028209) and could not be advanced further.The physician removed the stent from the patient and delivered a 0.014¿ x 200cm guidewire into the microcatheter; the guidewire was able to be delivered normally.The physician then changed to a new stent, a 4mm x 23mm enterprise 2 (encr402312 / 8269504) and advanced it into the microcatheter, but the new stent experienced the same issue.The physician removed the microcatheter and the stent from the patient¿s anatomy and observed that the microcatheter was kinked / bent at the proximal end.The physician replaced both the stent and the microcatheter with competitor brands to complete the procedure.The procedure was reportedly prolonged by approximately 20 minutes.There was no report of any negative patient impact.On 25-mar-2024, additional information was received.Per the information, the target vessel of the procedure was the anterior communicating artery.Adequate continuous flush was maintained through the microcatheter.The information indicated that for both stents: encr403012 and encr402312, ¿it was noted that when resistance was encountered, the stent was not pushed and retracted, leaving the stent on the guide wire¿ when they were removed.There were no damages observed on the stents.The guidewire was a competitor brand (unspecified).The information confirmed there was no negative patient impact.The physician did not consider the 20-minute procedure extension to be clinically significant.

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: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (31028209) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00325, and 3008114965-2024-00327.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 22-apr-2024.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00325, 3008114965-2024-00326, and 3008114965-2024-00327.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 150cm x 5cm prowler select plus microcatheter was received contained in the decontamination pouch.Visual inspection was performed.The microcatheter was observed kinked at 54.50cm from the proximal end.No other damages were found on the device.The inner diameter (id) and outer diameter (od) of the prowler select plus were confirmed to be within specifications.The microcatheter was flushed using a lab sample syringe.After flushing, a 0.018-inch (0.04572cm) lab sample guidewire was introduced into the microcatheter and it was advanced without any resistance and without any friction when it passed through the proximal aspect of the device.The guidewire got stuck when it reached the area where the kink was observed.The issues regarding the stent being impeded in the proximal section of the microcatheter, and the microcatheter being kinked can be confirmed based on the kink found on the proximal aspect of the device, which may have precluded the advancement of the enterprise devices.According to the risk documentation, the inability to connect the interventional device into the microcatheter and track to the desired location is a potential failure mode that can occur due to user technique.Inability to deliver therapeutic device to desired location can result from microcatheter damage during microcatheter insertion into the rhv or guiding / intermediate catheter o sheath.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.A review of manufacturing documentation associated with this lot (31028209) 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.The instructions for use (ifu) contains the following caution: if strong resistance is met during manipulation, discontinue the procedure, and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the catheter and guidewire as a system.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00325 and 3008114965-2024-00327.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 PLUS 150/5CM
• Type of Device: 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 ; 303552-689
• MDR Report Key: 19016347
• MDR Text Key: 340120106
• Report Number: 3008114965-2024-00326
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028888
• UDI-Public: 10886704028888
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 606S255X
• Device Lot Number: 31028209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/22/2024; 04/26/2024
• Supplement Dates FDA Received: 04/22/2024; 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0.014 GUIDEWIRE (UNSPECIFIED BRAND).; ENTERPRISE2 4MMX23MM.; ENTERPRISE2 4MMX30MM.