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

Model Number 606-S255X

Device Problems Material Too Soft/Flexible (4007); Physical Resistance/Sticking (4012)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Initial reporter name and address:(b)(6).The product was received in the product analysis lab on 29-mar-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.A review of manufacturing documentation associated with this lot (30936813) 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 2 products involved with the reported complaint.The associated manufacturer report numbers is 3008114965-2023-00210.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 the patient presented with intracranial stenosis underwent a vascular stent placement procedure on (b)(6) 2023.During the procedure, the 150cm x 5cm prowler select plus microcatheter (606s255x / 30936813) was placed in the target position and the physician delivered the complaint stent, a 4.5mm x 22mm enterprise® vascular reconstruction device (vrd) (enc452212 / 7187281) to the microcatheter.It was reported that the microcatheter moved back automatically.The stent was unable to pass through the microcatheter and could not be positioned.The physician removed both the microcatheter and the stent; both devices were replaced and the procedure was completed.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 the investigation finding of the returned device.[conclusion]: the healthcare professional reported that the patient presented with intracranial stenosis underwent a vascular stent placement procedure on (b)(6) 2023.During the procedure, the 150cm x 5cm prowler select plus microcatheter (606s255x/30936813) was placed in the target position and the physician delivered the complaint stent, a 4.5mm x 22mm enterprise® vascular reconstruction device (vrd) (enc452212/7187281) to the microcatheter.It was reported that the microcatheter moved back automatically.The stent was unable to pass through the microcatheter and could not be positioned.The physician removed both the microcatheter and the stent; both devices were replaced and the procedure was completed.There was no report of any negative patient impact.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this complaint file will be updated accordingly.The complaint device was returned for evaluation and analysis.The investigation finding 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.There was no appearance of damage observed.The inner diameter (id) and outer diameter (od) of the prowler select plus microcatheter were measured and confirmed to be within specifications.The device was flushed with a laboratory sample syringe.After that, a 0.018-inch lab sample guidewire was inserted into the microcatheter.The guidewire could be advanced until it came out from the distal tip of the microcatheter without noticeable resistance.The guidewire being able to pass through the entire length of the microcatheter indicated that it was not obstructed.Other circumstances or problems may have occurred during the use of the device that could not be replicated during the analysis.Therefore, the reported issue documented in the complaint regarding a microcatheter being obstructed was not confirmed.The issue regarding the microcatheter moving back automatically cannot be evaluated through functional testing because the reported issue is specific to the patient and procedure at the time of the occurrence and cannot be replicated in the laboratory.Additionally, there are no abnormalities or damages observed in the returned device that may have contributed or be secondary to the issue reported.According to the risk documentation, inability to track guidewire/microcatheter to desired location is a potential risk that can occur due to human anatomy (tortuosity).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 (30936813) 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.Although no product defect was identified, the instructions for use (ifu) provides the following precaution: do not attempt to use microcatheters 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00209 and 3008114965-2023-00210.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): CODMAN & SHURTLEFF, 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: 16640760
• MDR Text Key: 313152644
• Report Number: 3008114965-2023-00209
• 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
• Report Date: 04/05/2023

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 Model Number: 606-S255X
• Device Catalogue Number: 606S255X
• Device Lot Number: 30936813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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 4.5X22MM STENT 12 MM DW TIP