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

Catalog Number 606S255X

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Section e.1: the initial reporter phone: (b)(6).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.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00936.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.

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the physician encountered some resistance when the 4.5mm x 22mm no distal tip enterprise vascular reconstruction device (enc452200 / 6998479) was just delivered to the y-connector.The physician withdrew the stent and delivered it again, but the stent was impeded in the hub of the prowler select plus microcatheter (606s255x / lot# unknown) and could not be further advanced.The physician removed the microcatheter and the stent from the patient and switched to new devices to complete the procedure.There was no report of any negative patient impact.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 09-jan-2024.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00936 and 3008114965-2023-00937.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 include the additional event information received.[additional information]: additional information was received from the cerenovus sales representative on 28-dec-2023 and 04-jan-2024.The information are the same.Per the information, the target vessel was the anterior communicating artery.When the stent was removed, it was still on the delivery wire.The stent / stent delivery system did not appear damaged.A continuous flush had been maintained through the microcatheter.There were no visible kinks nor other damages observed on the microcatheter.Nothing unusual was noted about the system prior to use.The replacement stent was another 4.5mm x 22mm no distal tip enterprise vascular reconstruction device (enc452200) and the replacement microcatheter was another 150cm x 5cm prowler select plus microcatheter (606s255x).The information confirmed there was no negative patient impact and no delay in the procedure.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00936 and 3008114965-2023-00937.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 investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile prowler select plus microcatheter was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damages were observed.Microscopic inspection was performed along the body of the prowler, and no damages were found.The device was flushed with a laboratory sample syringe.After that, a lab sample enterprise system was introduced into the received microcatheter and was able to be advanced through the entire length of the microcatheter without noticeable resistance.The inner diameter (id) and outer diameter(od) of the microcatheter were confirmed to be within specifications.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.The enterprise system was able to pass through the entire length of the microcatheter without significant resistance, even through the distal portion.Additionally, no other damages were found on the microcatheter that could have contributed to the issue reported during the procedure.The customer complaint cannot be confirmed with the evidence available.It is possible that other clinical and procedural factors that cannot be replicated during the analysis may have contributed to the reported failure.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.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00936 and 3008114965-2023-00937.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: 18416539
• MDR Text Key: 331702785
• Report Number: 3008114965-2023-00937
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/01/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 12/28/2023; 01/09/2024; 02/01/2024
• Supplement Dates FDA Received: 01/04/2024; 01/09/2024; 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: EU ENT4.5MMD 22MML WNO DSTL TP