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 01/05/2024

Event Type  malfunction  

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.This is one of two products involved with the complaint and the associated manufacturer report numbers are (b)(4).

Event Description

As reported by the field, during a vascular stent placement, an eu 4.5x22mm stent 12 mm dw tip intracranial stent ((b)(6), 7632762) became impeded in the prowler select plus 150/5cm microcatheter (606s255x, 31040323) and could not pass through the microcatheter (mc).The physician removed the microcatheter and stent from the patient and switched new devices to complete the surgery.The stent body was found to be separated prematurely from the delivery wire.There was no patient injury reported.

Manufacturer Narrative

Product complaint #(b)(4).Section b5: additional event information received on 26-jan-2024 indicated that they were able to torque the device.There was no evidence of physical material within the device.The resistance was felt at the distal end of the microcatheter.No other devices were successfully used with the concomitant device prior to the encountered resistance.The mc did kink.No excessive force was used with the stent.There was no procedural delays due to the event.Complaint conclusion: as reported by the field, during a vascular stent placement, an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 7632762) became impeded in the prowler select plus 150/5cm microcatheter (606s255x, 31040323) and could not pass through the microcatheter (mc).The physician removed the microcatheter and stent from the patient and switched new devices to complete the surgery.The stent body was found to be separated prematurely from the delivery wire.There was no patient injury reported.Additional event information received on 26-jan-2024 indicated that they were able to torque the device.There was no evidence of physical material within the device.The resistance was felt at the distal end of the microcatheter.No other devices were successfully used with the concomitant device prior to the encountered resistance.The mc did kink.No excessive force was used with the stent.There was no procedural delays due to the event.A non-sterile prowler select plus 150/5cm microcatheter was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and 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 microcatheter was confirmed to be within specifications for the inner diameter (id) and outer diameter (od).A manufacturing record evaluation was performed for the finished device 31040323 number, and no non-conformances related to the malfunction were identified.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 (i.E., no kink or bents) that could have been related to the issues 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 cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.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.

• 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 ; 3035526892
• MDR Report Key: 18562461
• MDR Text Key: 333458376
• Report Number: 3008114965-2024-00115
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• 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: 31040323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2023
• 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: EU 4.5X22MM STENT 12 MM DW TIP
• Patient Age: 53 YR
• Patient Sex: Female