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

Model Number 606-S255X

Device Problems Contamination /Decontamination Problem (2895); Physical Resistance/Sticking (4012)

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

Event Date 09/13/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during an embolectomy procedure targeting an occlusion in the basilar artery, the delivery wire was impeded in the tip of the 150cm x 5cm, 2 markers prowler select plus microcatheter (606s255x / 30481244) during its delivery to the target position.The physician withdrew the microcatheter from the patient¿s body and one foreign matter of unknown material was observed.The prowler select plus microcatheter was replaced with another microcatheter and the procedure as completed.There was no report of any patient injury or adverse event associated with the reported issue.Six (6) photos were included in the complaint.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Initial reporter phone: (b)(6).The initial reporter email address was not reported.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 complaint was accompanied by six (6) photos.The photos were reviewed by the product analysis lab and is documented below.[photo analyses]: based on the photos included in the complaint file, the complaint device can only be seen in one of the six photos.The device is still inside the package and observation / evaluation of the device cannot be made.The rest of the remaining photos are of the device packaging that can be observed to be already opened.No damages were observed.The sealed pouch is observed opened and with fold marks.One of the images shows a black particle that is outside the device packaging.The device was not shown in this image.At this time, it cannot be determined what and where the origin of this particle is.The issue reported related to the obstructed body of the microcatheter cannot be evaluated based on the photos.The issue related to the foreign particle cannot be confirmed / evaluated based on the photos.A review of manufacturing documentation associated with this lot (30481244) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The manufacturing record evaluation concludes that the issue reported are not related to the manufacturing process.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 include the additional event information received on 24-oct-2021.[additional information]: the healthcare professional reported that during an embolectomy procedure targeting an occlusion in the basilar artery, the delivery wire was impeded in the tip of the 150cm x 5cm, 2 markers prowler select plus microcatheter (606s255x / 30481244) during its delivery to the target position.The physician withdrew the microcatheter from the patient¿s body and one foreign matter of unknown material was observed.The prowler select plus microcatheter was replaced with another microcatheter and the procedure as completed.There was no report of any patient injury or adverse event associated with the reported issue.On 24-oct-2021, additional information was received.The information indicated that there was no visible damages such as kinks observed on the microcatheter.The foreign material was the cause for the delivery wire being impeded at the tip of the microcatheter.There was no damage observed on the packaging of the microcatheter; the inner pouch that contained the microcatheter was securely sealed and the sterile pouch integrity was not compromised.The procedure was completed with replacement device.The reported event did not result in a clinically significant delay in the procedure.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 01-nov-2021.A supplemental 3500a report will be submitted once the product investigation has been completed.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 investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an embolectomy procedure targeting an occlusion in the basilar artery, the delivery wire was impeded in the tip of the 150cm x 5cm, 2 markers prowler select plus microcatheter (606s255x / 30481244) during its delivery to the target position.The physician withdrew the microcatheter from the patient¿s body and one foreign matter of unknown material was observed.The prowler select plus microcatheter was replaced with another microcatheter and the procedure as completed.There was no report of any patient injury or adverse event associated with the reported issue.On 24-oct-2021, additional information was received.The information indicated that there was no visible damages such as kinks observed on the microcatheter.The foreign material was the cause for the delivery wire being impeded at the tip of the microcatheter.There was no damage observed on the packaging of the microcatheter; the inner pouch that contained the microcatheter was securely sealed and the sterile pouch integrity was not compromised.The procedure was completed with replacement device.The reported event did not result in a clinically significant delay in the procedure.The complaint was accompanied by six (6) photos.The photos were reviewed by the product analysis lab and is documented below.[photo analyses]: based on the photos included in the complaint file, the complaint device can only be seen in one of the six photos.The device is still inside the package and observation / evaluation of the device cannot be made.The rest of the remaining photos are of the device packaging that can be observed to be already opened.No damages were observed.The sealed pouch is observed opened and with fold marks.One of the images shows a black particle that is outside the device packaging.The device was not shown in this image.The issue related to the foreign particle cannot be confirmed / evaluated based on the photos.The manufacturing record evaluation concludes that the issue reported are not related to the manufacturing process.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 150cm x 5cm, 2 markers prowler select plus microcatheter was returned coiled and contained in a pouch.The device underwent visual inspection and was observed to be in good, normal condition.There were no damages nor anomalies observed during the visual inspection.The reported foreign particle captured in the photo was not observed.It is possible that the particle fell off during shipping or possibly during the decontamination process, however, this cannot be conclusively determined.Dimensional analysis: the inner diameter (id) and outer diameter (od) of the returned complaint device were measured and found to be within specifications.Hub id specification = 0.021 inch; minimum; actual measurement: 0.0215 inch.Distal id specification = 0.021 inch; minimum; actual measurement: 0.0215 inch.Actual microcatheter od (17.7165 inch from distal end); specification: max.0.0375 inch; actual measurement: 0.0352 inch.Actual microcatheter od (1.9685 inch from distal end); specification: max.0.032 inch; actual measurement: 0.0305 inch.Functional test: the 150cm x 5cm, 2 markers prowler select plus microcatheter was flushed using a lab sample syringe.A lab sample guidewire was then inserted into the microcatheter and advanced to the distal tip without any difficulty.There was no resistance / friction experienced.There was nothing noted to be obstructing the microcatheter during the functional test.A review of manufacturing documentation associated with this lot (30481244) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint documented that the delivery wire was impeded in the tip of the 150cm x 5cm, 2 markers prowler select plus microcatheter during its delivery to the target position during an embolectomy procedure targeting an occlusion in the basilar artery.When the physician withdrew the microcatheter from the patient¿s body and one foreign matter of unknown material was observed.There was no visible damage noted on the microcatheter and it was reported that it was the foreign material that caused the delivery wire to be impeded at the tip of the microcatheter.The complaint included six (6) photos which were reviewed by the product analysis lab.Of the six photos, only one shows a black particle outside the device packaging.It was not possible to determine the composition / structure of the foreign material, and the source of origin remains unknown based on the photo.The particle was not observed on the returned device.The device dimensions were measured and checked against specifications; all measurements were within specifications.Functional evaluation was performed and a lab guidewire was advanced through the microcatheter without any resistance / friction encountered.Based on the analysis and evaluation performed on the returned device, the reported issue documented in the complaint was not confirmed.The manufacturing record evaluation was also reviewed; there is no indication that the event is related to the device manufacturing process.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendation: 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 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.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): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12558451
• MDR Text Key: 281204813
• Report Number: 3008114965-2021-00463
• 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,Followup,Followup,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 606-S255X
• Device Catalogue Number: 606S255X
• Device Lot Number: 30481244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• 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