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 08/21/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during a vascular stent placement procedure in a patient who presented with intracranial stenosis, a 150cm x 5cm prowler select plus microcatheter (606s255x / 31032658) was placed in the target site and a 4mm x 16mm enterprise 2 vascular reconstruction device (vrd) (encr401612 / 7773929) was delivered into the microcatheter.The stent was impeded in the distal end of the microcatheter and could not pass through.The physician retracted the microcatheter and stent from the patient¿s anatomy and switched to new devices to complete the procedure.There was no report of any negative patient impact.The complaint included three (3) photos of the devices.The cerenovus sales representative provided additional information on 28-aug-2023.The information indicated that the targeted location was stenosis of the m1 segment of the middle cerebral artery (mca).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, it was still on the delivery wire.The delivery wire was not reshaped prior to use.The replacement stent was another 4mm x 16mm enterprise 2 vascular reconstruction device (encr401612) and the replacement microcatheter was another 150cm x 5cm prowler select plus (606s255x).The information confirmed there was no negative patient impact; the physician did not consider the 20-minute procedure delay to be clinically significant.

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 e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.3: 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.The product analysis team reviewed the photos included in the complaint.The review is documented below.[photo review]: two (2) of the three photos included in the complaint showed the prowler select plus microcatheter to be coiled, and no visible damages were noted.Some residues of dried blood can be seen in the hub.In the second photo, only one (1) portion of the device was shown and a slight kink was noted.A review of manufacturing documentation associated with this lot (31032658) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The reported issue documented in the complaint regarding the microcatheter being kinked and impeded was confirmed based on the kinked condition observed in the photo.This may be secondary to the reported issue.This investigation was performed based only on the photos provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00608.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 03-oct-2023.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00608 and 3008114965-2023-00609.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 150cm x 5cm prowler select plus microcatheter was received contained in the decontamination pouch.Visual inspection was performed.Dried blood residues were noted at the luer hub of the microcatheter.Several compressed areas were noted along the entire shaft and brite tip of the microcatheter.The distal tip was also observed to be compressed.One (1) bent area was noted at 30 cm from the proximal end of the device.The inner diameter (id) and outer diameter (od) of the microcatheter were confirmed to be within specifications.The attempt to flush the microcatheter was unsuccessful, it was obstructed and strong resistance was felt between the lab sample guidewire and the microcatheter.The microcatheter was then dissected, and it was confirmed to be obstructed by dried blood residues.A review of manufacturing documentation associated with this lot (31032658) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The issue reported regarding the microcatheter being kinked and obstructed was confirmed based on the findings mentioned above.The blood residues found inside the microcatheter suggest that an adequate flush was not maintained, resulting in a blockage that could have led to the strong resistance felt during the advancement of the enterprise system, which could have led to excessive force inadvertently applied to overcome the resistance.According to the risk documentation an adequate continuous flush not maintained is a potential failure mode that can cause air in system or stagnant blood.Also, 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.The compressed sections found in the brite tip are suggested to be the result of the rotating hemostasis valve (rhv) not being sufficiently opened during the device removal.The rest of the compressed conditions on the shaft of the microcatheter were not shown on the previous pictures provided.Since the damages were not originally reported, they are not considered related to the reported failure.Although no conclusion could be reached as to the cause of the event reported, it should be noted that product failure is multifactorial.The instructions for use (ifu) states that 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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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: 3008114965-2023-00608 and 3008114965-2023-00609.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.

• 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: 17715875
• MDR Text Key: 323189276
• Report Number: 3008114965-2023-00609
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2023

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
• Device Lot Number: 31032658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 10/03/2023; 10/10/2023
• Supplement Dates FDA Received: 10/03/2023; 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 4MMX16MM