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 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.4: the expiration date of the device is not known as the device lot number is not available / not reported.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.The product analysis team reviewed the one (1) photo included in the complaint of the prowler select microcatheter.The review is documented below.[photo review]: one (1) phot was included in the complaint file.The photo showed a prowler select plus microcatheter coiled.The entirety of the device cannot be evaluated due to the photo resolution and the distance from where the photo was taken.However, a kink is observed on the proximal end of the microcatheter.No further appearance of damage is observed.The issue reported that the stent was impeded in the proximal of the microcatheter cannot be confirmed since the microcatheter needs to be subjected to functional test and dimensional inspection.The issue reported that the microcatheter was found to be kinked/bent was confirmed based on the kink damage observed in the photo; it is possible that such damage may have contributed to the inability to further advance the stent.This investigation was performed based only on the photo provided.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the additional event information received on 01-sep-2023, the microcatheter had been discarded and is no longer available to be returned.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.With the information available and without the complaint product available to be returned for analysis, the reported issue documented in the complaint cannot be confirmed through functional evaluation and analysis.The lot number of the device is not known; therefore, manufacturing documentation review was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00602.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that the patient presented with an aneurysm underwent an endovascular embolization procedure.During the procedure, a 4 mm x 39 mm enterprise®2 stent (encr403912 / 8028676) was impeded in the proximal section of the 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown) and could not be further advanced.The physician removed the microcatheter and the enterprise stent from the patient¿s anatomy and switched to new devices to complete the procedure.It was reported that the procedure was prolonged by approximately 20 minutes.There was no report of any negative patient impact.The complaint included one photo of the one of the complaint 150cm x 5cm prowler select plus microcatheter.The cerenovus sales representative provided additional information on 28-aug-2023.The information indicated the location of the target aneurysm was unobtainable.Before the reported kinked / bent was observed on the microcatheter, a continuous flush had been maintained through it.When the stent was removed from the patient after the second attempt to use it, it remained in the microcatheter.Nothing unusual was noted about the system prior to use.The replacement stent was another 4 mm x 39 mm enterprise®2 stent (encr403912); however, the replacement microcatheter was not another 150cm x 5cm prowler select plus (606s255x).Per the additional information, the replacement microcatheter was ¿a domestic product.¿ information whether there was any prolonged hospitalization or any negative impact to the patient was alleged could not be obtained.The physician did not consider the 20-minute procedure extension to be clinically significant.On 01-sep-2023, additional information was received.Per the cerenovus sales representative, the concomitant 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown) was discarded and is no longer available to be returned.

• 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 ; 303552-689
• MDR Report Key: 17706204
• MDR Text Key: 322938900
• Report Number: 3008114965-2023-00603
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606S255X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2023
• Initial Date FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: No
• 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 4MMX39MM