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

Catalog Number 606151X

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

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

As reported by the field, during a coil embolization to the cervical segment of intracranial artery, a prowler-14 dual marker microcatheter (606151x, 30802064) was placed in target site.The physician delivered an unspecified coil into microcatheter (mc) and detached the coil in aneurysm.The microcatheter was found to be migrated into the aneurysm.Doctor retracted the microcatheter and switched to a new microcatheter (other brand) to complete the surgery.There was no patient injury reported.Additional information received on 07-oct-2023 indicated that there was no resistance felt at any point during procedure.There was no relevant anatomical information including vessel characteristics.There was no damage to the microcatheter during manipulation of the device or noticed to be damaged upon removal from the patient.A continuous flush on the microcatheter was maintained.No excessive force was applied to the device.

Manufacturer Narrative

Product complaint # :(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).Section h3 - 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.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 company is seeking this information through the event investigation.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.

Manufacturer Narrative

Product complaint # (b)(4).A non-sterile prowler-14 dual marker microcatheter was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and one (1) compressed condition was found from 5.4 cm to 6.8 cm.Four (4) kinked conditions were found; the first at 10 cm, the second at 10.2 cm, the third at 15.5 cm, and the fourth at 20.6 cm.All measurements were taken from the distal end of the microcatheter.No other damages were observed.The microcatheter was confirmed to be within specifications for the inner diameter (id) and outer diameter (od).Microcatheter flushing was attempted, but it was found obstructed, and strong resistance was felt between the lab-sample guidewire and microcatheter at 92 cm from the proximal end of the microcatheter.The microcatheter was then dissected, and it was confirmed to be obstructed by dried saline residues.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the microcatheter migrating into the aneurysm cannot be evaluated through functional testing since the reported issue is specific to the patient and procedure at the time of occurrence and cannot be replicated in the laboratory; however, according to the risk documentation, the inability to track guide wire / microcatheter to the desired location is a potential issue that can occur during the tracking of the microcatheter over the guidewire to the target position due to an improper technique used and / or human anatomy (tortuosity).The accumulation of dried saline residues inside the microcatheter suggests that an adequate flush was not maintained; however, this condition, the compressed condition, and the kinked conditions found are not considered related to the inadequate support of the microcatheter, since according to the sequence of events described, no damages were observed on the microcatheter during its manipulation nor removal.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.As part of 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.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure is multifactorial.The instructions for use (ifu) provide 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.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.

Manufacturer Narrative

Product complaint (b)(4).Complaint conclusion: as reported by the field, during a coil embolization to the cervical segment of intracranial artery, a prowler-14 dual marker microcatheter (606151x, 30802064) was placed in target site.The physician delivered an unspecified coil into microcatheter (mc) and detached the coil in aneurysm.The microcatheter was found to be migrated into the aneurysm.Doctor retracted the microcatheter and switched to a new microcatheter (other brand) to complete the surgery.There was no patient injury reported.Additional information received on 07-oct-2023 indicated that there was no resistance felt at any point during procedure.There was no relevant anatomical information including vessel characteristics.There was no damage to the microcatheter during manipulation of the device or noticed to be damaged upon removal from the patient.A continuous flush on the microcatheter was maintained.No excessive force was applied to the device.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30802064 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The instructions for use (ifu) contain 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 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.

Manufacturer Narrative

Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: PROWLER-14 DUAL MARKER
• 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 ; 3035526892
• MDR Report Key: 18003631
• MDR Text Key: 326487271
• Report Number: 3008114965-2023-00770
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028628
• UDI-Public: 10886704028628
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K972518
• 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,Followup,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606151X
• Device Lot Number: 30802064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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: UNSPECIFIED COIL