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 Thromboembolism (2654)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Section e1.(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.Obstruction with microcatheter while-in patient with loss of cerebral target position will require re-accessing the target site with increased potential for vessel trauma, vessel spasm, and/or ischemia/infarct.As for catheter body/shaft -kink/bent while in patient, catheter kinking/damage during clinical use is a known and common occurrence occurring during angiography and is typically related to anatomy, technique, skill, and vessel tortuosity.The instructions for use (ifu) cautions users to inspect for kinks and bends, or other signs of damage prior to and during use.Any product with damage is not to be used.If the operator encounters kinking or damage during use, they are clinically trained to immediately discontinue manipulations and remove the product.Therefore, the potential for patient injury/death occurring as a result of kinking or bend type damage is remote.In this case, the events may have contributed to a thromboembolism.The severity of the event is unknown.Based on this information, this event does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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.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.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 3011370111-2024-00026.

Event Description

It was reported, via a healthcare professional, that an embotrap ii 5x33 revasc.Dev.(et007533/22c234av) and a prowler select plus 150/5cm (606s255x/ 31108274) was used for a thrombectomy procedure.During the procedure, the user reported embotrap - impediment in microcatheter with loss of cerebral target position, kinking of the embotrap shaft, and prowler select plus - obstruction-in patient with loss of microcatheter cerebral target position and body/shaft kink/bent while in patient.During the events, a thromboembolism was observed.The event was reported as such, ¿impeded& kinked/bent.It was reported that during procedure, when delivering the microcatheter to the target site, the microcatheter encountered some resistance in the patient.The physician retracted the microcatheter and managed delivering the microcatheter to the vicinity of the target site and then started to deliver the stent into the microcatheter.The stent was impeded at the distal end of the microcatheter and could not pass through the microcatheter.The physician removed the microcatheter and stent from the patient.The delivery wire and microcrater were found be to kinked/bent.Thrombus was also found to run into the distal branch vessel and occluded the vessel.The physician switched new devices (both are other brands) to complete the surgery.The procedure was prolonged about 10 minutes.¿ patient outcome is unknown.No further information was made available at the time of this review.Additional information was received on 07-apr-2024.Summary: per the information, the location of target lesion was the middle cerebral artery (mca).The patient¿s outcome was said to be ¿good recovery.¿ the 10-minute prolonged surgery was not considered to be clinically significant.Regarding what the physician thinks may have caused or contributed to thrombosis; it was said ¿possibly no balloon used for flow closure.¿ it is unknown if or how the event was treated, as this information was ¿unobtainable.¿ the insertion tool was securely placed in the hub of the microcatheter prior to attempting to advance the embotrap.The technique used to hold the insertion tool in position during advancement of the device was ¿locking y-valve.¿ the device was flushed without difficulty.Regarding how many passes were made to attempt to retrieve the clot, it was said, ¿retrieval stent advancement obstructed, and cannot make to retrieve the clot.¿ there was no evidence of physical material within the devices.

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.

Manufacturer Narrative

Product complaint # (b)(6).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h10.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 one kinked condition was found at 89.50cm from the proximal end.The microcatheter was confirmed to be within specifications for the inner diameter (id) and outer diameter (od).The device was flushed with a laboratory sample syringe.After that, a lab sample 4.5 x 28 mm enterprise system was introduced into the received microcatheter to emulate the concomitant embotrap, and was able to be advanced through the entire length of the microcatheter without noticeable resistance.A manufacturing record evaluation was performed for the finished device 31108274 number, and no non-conformances related to the malfunction were identified.The issue regarding a stent being impeded on the distal portion of the microcatheter cannot be confirmed.The enterprise system was able to pass through the entire length of the microcatheter without significant resistance, even through the distal portion.However, the issue regarding a catheter being kinked was confirmed.This condition is deemed unrelated to the reported impeding during the procedure, as the enterprise system successfully reached the microcatheter's distal end despite this.It is possible that other clinical and procedural factors that cannot be replicated during the analysis may have contributed to the reported failure.According to the risk documentation, insufficient flushing is a potential failure mode that can compromise the performance of the therapeutic device, and a microcatheter being damaged or kinked during use is a potential issue that can occur due to device handling during the procedure.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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: 19115421
• MDR Text Key: 340270027
• Report Number: 3008114965-2024-00405
• 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,Followup
• Report Date: 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606S255X
• Device Lot Number: 31108274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/29/2024; 05/06/2024
• Supplement Dates FDA Received: 04/30/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• 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: EMBOTRAP II 5X33 REVASC. DEV.
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian