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

Model Number 606-S255X

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

As reported by the field, angiographically confirmed the patient suffered from a right ophthalmic artery segment bilateral aneurysm and planned to perform coil embolization of the aneurysm.After vascular access was established, an unspecified coil filled in the aneurysm.It was found that the coil could not maintain an effective shape, then performed stent-assisted coil embolization of the aneurysm.A prowler select plus 150/5cm (606s255x, 30772062) was placed in target position, an enterprise2 4mmx23mm intracranial neurovascular stent (encr402312, 7048258) was advanced within the microcatheter (mc), but the stent was impeded in the middle part of the microcatheter, and it could not advance or withdraw.After several attempts, the delivery wire of the stent was able to withdraw, then the physician retracted the stent to introducer sheath and observed the stent body was released in the microcatheter.A new stent and microcatheter were switched to complete the surgery.There was no patient injury report.

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.One picture was attached to the complaint file in which can be noted one section of the involved prowler.No damages can be appreciated on it.It was noted that the involved enterprise stent was detached inside of the hub.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The customer complaint was not able to be confirmed since a functional test needs to be performed.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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 3008114965-2022-00806.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).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, and h10.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 #
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> pc-(b)(4).Section b5: additional information received indicated that the coil that could not maintain an effective shape was of a competitor¿s brand.No torquing device was used.There was no evidence of physical material within the device.A synchro delivery wire was used successfully with the concomitant device before the encountered issue.There were no procedural delays due the event.Complaint conclusion: as reported by the field, angiographically confirmed the patient suffered from a right ophthalmic artery segment bilateral aneurysm and planned to perform coil embolization of the aneurysm.After vascular access was established, an unspecified coil filled in the aneurysm.It was found that the coil could not maintain an effective shape, then performed stent-assisted coil embolization of the aneurysm.A prowler select plus 150/5cm ((b)(6), (b)(6)) was placed in target position, an enterprise2 4mmx23mm intracranial neurovascular stent ((b)(6), (b)(6)) was advanced within the microcatheter (mc), but the stent was impeded in the middle part of the microcatheter, and it could not advance or withdraw.After several attempts, the delivery wire of the stent was able to withdraw, then the physician retracted the stent to introducer sheath and observed the stent body was released in the microcatheter.A new stent and microcatheter were switched to complete the surgery.There was no patient injury reported.Additional information received indicated that the coil that could not maintain an effective shape was of a competitor¿s brand.No torquing device was used.There was no evidence of physical material within the device.A synchro delivery wire was used successfully with the concomitant device before the encountered issue.There were no procedural delays due the event.One picture was attached to the complaint file in which can be noted one section of the involved prowler.No damages can be appreciated on it.It was noted that the involved enterprise stent was detached inside of the hub.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 no apparent damage was noted.It was found that the involved stent was detached inside of the hub.This condition is consistent with the condition seen in the provided picture.The stent was removed without noticeable resistance.A microscopic inspection of the entire device's length was performed, and the microcatheter was found undamaged (i.E., no kink, no bent or compressed).The inner diameter (id) and outer diameter (od) were measured, and they were found to be within specifications.The device was flushed with a laboratory sample syringe.After that, a.018-inch lab sample guidewire was inserted into the received microcatheter.The guidewire could be advanced until it came out from the distal tip of the microcatheter without noticeable resistance.Although the functional test could not be performed with the involved enterprise system, the guidewire being able to pass through the entire length of the microcatheter indicated that it was not obstructed.Additionally, no damages were found on the microcatheter that could have contributed to the issue encountered during the procedure.Other circumstances or problems may have occurred during the use of the device that could not be replicated during the analysis.Therefore, the customer complaint was not confirmed.It should be noted that product failure could be caused by multiple factors.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 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.

• 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: 15917574
• MDR Text Key: 308090447
• Report Number: 3008114965-2022-00807
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• 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: 30772062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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: ENTERPRISE2 4MMX23MM
• Patient Sex: Female