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

Model Number 606-S255X

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

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).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.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00812.

Event Description

As reported by the field, during a stent assist coil embolization to the mi segment of the middle cerebral artery, a prowler select plus 150/5cm microcatheter (606s255x, 30706398) was placed in the lesion site.However, a cnv stent (product name, code and lot not known) became impeded in the microcatheter tip and could not pass through it.The physician retracted the microcatheter (mc) and switched to a new one to complete the surgery (the stent was not replaced).There was no patient injury reported.Additional information received indicated that the microcatheter was found to be kinked/bent during the procedure of delivering the stent to the microcatheter.Nothing was noted to be obstructing the microcatheter.There was no excessive force applied to the device.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h10.Complaint conclusion: as reported by the field, during a stent assist coil embolization to the mi segment of the middle cerebral artery, a prowler select plus 150/5cm microcatheter (606s255x, 30706398) was placed in the lesion site.However, a cnv stent (product name, code and lot not known) became impeded in the microcatheter tip and could not pass through it.The physician retracted the microcatheter (mc) and switched to a new one to complete the surgery (the stent was not replaced).There was no patient injury reported.Additional information received indicated that the microcatheter was found to be kinked/bent during the procedure of delivering the stent to the microcatheter.Nothing was noted to be obstructing the microcatheter.There was no excessive force applied to the device.A non-sterile prowler select plus 150/5cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and one (1) compressed condition was found from 0.2 cm to 0.5 cm of the distal end of the microcatheter.The microcatheter was flushed using a lab sample syringe.After that, a guide wire 0.04572 cm lab sample was introduced, and it advanced, then the wire could pass through the flattened portion of the device without any difficulty.The device was confirmed to be within specifications from the inner diameter (id) and outer diameter (od) on the non-damaged portions.The customer complaint as related to the microcatheter being kinked could not be confirmed since such damage was not observed on the returned device.The customer complaint regarding the microcatheter being obstructed could not be replicated in the laboratory as the functional test was performed and no issues were observed; however, the complaint detailed that the stent could not pass through the microcatheter tip, and based on the appearance of the returned device, it is possible that the flattened segment observed may have contributed to the issue encountered during the procedure.According to the risk documentation, inability to deliver therapeutic device to desired location is a risk associated to the microcatheter damage during use, specifically, during insertion of the microcatheter into the rotative hemostasis valve (rhv) of guiding/intermediate catheter or sheath.Other factors such as the vessel tortuosity detailed in the complaint information, may have contributed to the issue encountered; there is no indication that the issue reported is a result of a defect inherently related to the device.A manufacturing record evaluation was performed, and no non-conformances were identified.It should be noted that product failure is multifactorial.The instructions for use contain the following precaution: ¿ do not use a catheter that has been damaged in any way.Damaged catheters may rupture causing vessel damage or tip detachment during the procedure.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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 ; 3035526892
• MDR Report Key: 15932235
• MDR Text Key: 307778626
• Report Number: 3008114965-2022-00811
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• 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: 30706398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• 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: STENT - VASCULAR RECONSTRUCTION.