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 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.(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 ten (10) photos.The photos were reviewed by the product analysis lab and is documented below.[photo analyses]: ten (10) photos were included in the complaint.Most of the photos showed the package and the labels from the complaint device.The package is noted to be open without any damages.In one photo, the prowler select plus microcatheter is captured in one bucket with clear liquid.No damages were observed on the complaint microcatheter.One photo showed a piece of gauze inside the same bucket as the microcatheter, in this photo, on top of the gauze, a small particle of unknown origin is observed.No other damage was observed.The reported issues related to the catheter obstructing the delivery wire and the foreign material observed when the microcatheter was removed from the patient¿s body could not be confirmed based on the photos that accompanied the complaint.Further investigation will be performed when the device is returned for evaluation and analysis.A review of manufacturing documentation associated with this lot (30539966) 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.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.

Event Description

The healthcare professional reported that during a stent implantation for intracranial vascular stenosis procedure, the delivery wire was impeded in the tip of the 150cm x 5cm prowler select plus microcatheter (606s255x / 30539966) during the attempt to deliver the device to the target position.The physician withdrew the microcatheter from the patient¿s body and two black spots of unknown material were 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.Ten (10) photos of the device with the spots were included in the complaint.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 26 september 2021.[additional information]: the healthcare professional reported that during a stent implantation for intracranial vascular stenosis procedure, the delivery wire was impeded in the tip of the 150cm x 5cm prowler select plus microcatheter (606s255x / 30539966) during the attempt to deliver the device to the target position.The physician withdrew the microcatheter from the patient¿s body and two black spots of unknown material were 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 26 september 2021, additional information was received.The information indicated that the target of the procedure was on the right middle cerebral artery (mca).When the black spots were noted, no stent was being used with the microcatheter.There was no visible damage noted on the microcatheter.The information indicated that the black spots were the cause for the delivery wire being impeded at the tip.There was no damage on the microcatheter packaging.The inner pouch was securely sealed.The integrity of the sterile pouch was not compromised.Prior to the delivery wire, no other device as used with the microcatheter.Another microcatheter was used to complete the procedure.The reported issue did not result in any 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 05 october 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 a stent implantation for intracranial vascular stenosis procedure, the delivery wire was impeded in the tip of the 150cm x 5cm prowler select plus microcatheter (606s255x / 30539966) during the attempt to deliver the device to the target position.The physician withdrew the microcatheter from the patient¿s body and two black spots of unknown material were 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 26 september 2021, additional information was received.The information indicated that the target of the procedure was on the right middle cerebral artery (mca).When the black spots were noted, no stent was being used with the microcatheter.There was no visible damage noted on the microcatheter.The information indicated that the black spots were the cause for the delivery wire being impeded at the tip.There was no damage on the microcatheter packaging.The inner pouch was securely sealed.The integrity of the sterile pouch was not compromised.Prior to the delivery wire, no other device as used with the microcatheter.Another microcatheter was used to complete the procedure.The reported issue did not result in any clinically significant delay in the procedure.The complaint was accompanied by ten (10) photos.The photos were reviewed by the product analysis lab and is documented below.[photo analyses]: ten (10) photos were included in the complaint.Most of the photos showed the package and the labels from the complaint device.The package is noted to be open without any damages.In one photo, the prowler select plus microcatheter is captured in one bucket with clear liquid.No damages were observed on the complaint microcatheter.One photo showed a piece of gauze inside the same bucket as the microcatheter, in this photo, on top of the gauze, a small particle of unknown origin is observed.No other damage was observed.The reported issues related to the catheter obstructing the delivery wire and the foreign material observed when the microcatheter was removed from the patient¿s body could not be confirmed based on the photos that accompanied the complaint.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 150cm x 5cm prowler select plus microcatheter was received coiled and contained in a pouch.Visual inspection performed noted the device in good, normal condition.A foreign material was observed adhered to the hub wall.There were no other damages nor anomalies observed.Dimensional analysis: the foreign matter / material was removed from the hub and the dimensions of the returned device were measured.The inner diameter (id) and outer diameter (od) were measured and confirmed to be within specifications.Hub id = 0.0215 inch; specification: 0.021 inch minimum.Distal id = 0.0215 inch; specification: 0.021 inch minimum.Actual microcatheter od (17.7165 inch from distal end) 0.0353 inch; specification: max.0.0375 inch.Actual microcatheter od (1.9685 inch from distal end) 0.0308 inch; specification: max.0.032 inch.Functional evaluation: the returned 150cm x 5cm prowler select plus microcatheter was flushed using a lab sample syringe.After the device was flushed, a lab sample guidewire was introduced / inserted into the microcatheter and advanced until it reached the distal tip.The guidewire was able to advance without any difficulty; no resistance / friction was felt during the advancement of the guidewire.The complaint documented that the black spots were the cause for the delivery wire being impeded at the tip of the microcatheter, the foreign material was not present inside the catheter¿s body.It may have gotten lost / shaken loose during post-operative handling or decontamination process.Based on the results of the functional test, the reported issue that the delivery wire was impeded at the tip of the microcatheter was not confirmed.The foreign material / matter was submitted for fourier-transform infrared spectroscopy (ftir) analysis to determine the material composition and its potential source.Fourier transform infrared spectroscopy (ftir) is a characterization method that provides information of characteristic molecular vibrations of materials according to infrared radiation absorbance, transmittance, and reflectance.It is an extremely useful analytical technique, providing specific information about functional groups, chemical bonding, and molecular structure, most suitably for organic materials.This technique is based on the fact that bonds vibrate at characteristic frequencies.When exposed to infrared radiation, a molecule selectively absorbs energy at infrared frequencies that match those of its allowed vibrational modes.Therefore, the infrared absorption spectrum of a material reveals which vibrations, and thus functional groups, are present in its structure.Infrared spectroscopy is an effective analytical instrument for detecting functional groups and characterizing covalent bonding information.Foreign material was tested by infrared spectroscopy with no further preparation.The ftir measurements were performed using an is50 nicolet ftir mir spectrophotometer, equipped with an atr accessory.The spectra were recorded in the region between 4000-650 cm^-1, with a spectral resolution of 4 cm^-1 and 32 scans.The material present characteristic n-h stretching vibrations at 3233 cm^-1 with an o-h bond overlap, followed by aliphatic c-h stretching vibrations at 2921 cm^-1.Moving forward, two characteristic peaks attributed to c=o stretching vibrations of amide i and amide ii bending vibrations of hydrogen bonds at 1629 and 1571 cm^-1 can be observed.At 1482 cm^-1 and 1402 cm^-1 scissoring vibrations of ch2 and bending mode of ch3 are detected.Characteristic bands related to nitrogen bonds can be seen at 1318, 1285 and 1234 cm^-1 attributed to n-h wagging of amides, c-n bonds from aliphatic groups and amide iii vibrations (n-h bending, c-n and c-c stretching) respectively.The peaks located at 1144, 1099, 1070 and 1010 cm^-1 can be attributed to c-o-ch symmetric bending vibrations, c-oh, and c-h bond deformations along with n-o, c-n stretching.Finally, two vibration peaks located at 870 cm^-1 and 833 cm^-1 can be assigned to ch2 rocking and twisting along with c=o deformations.From the obtained results the presence of carboxylic acid salts is ruled out since there is no presence of characteristic vibrational modes of carbonyl functional group at range of 1715 cm^-1, also, the molecule is mainly composed of aliphatic alcohols, amides and hydrocarbons ruling out any aromatic vibrations due to c-h and c-c vibrations.The final task performed as part of this investigation was a comparison test between the foreign material, 64d nylon compound reference material used in prowler select plus 150/5 cm microcatheter fabrication and biological reference material.The ftir spectra shows characteristic vibrations of both biologic based material and 64d nylon material, sharing the composition of amide compounds in their structure.The most relevant peak in the fingerprint region of the 64d nylon spectra is located at 1109 cm^-1 related to c-n bonds, however peak intensity in the region of 1300-1200 cm^-1 ant the absence of the doublet located at 871 cm^-1 and 833 cm^-1 states that the material composition is more complex and could not be assigned to microcatheter material.Overall, ftir data reveals that the foreign material shares some characteristics with 64d nylon compound and a biologic-based material due to amide vibrational modes, however the complete chemical composition cannot be totally assigned due to relevant shifts and extra peaks in the spectrum, which are not related to the microcatheter fabrication.Source of origin remains unknown.Based on the finding during the ftir analysis, the customer complaint regarding the foreign material was confirmed.A review of manufacturing documentation associated with this lot (30539966) 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.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: 12465599
• MDR Text Key: 280768584
• Report Number: 3008114965-2021-00425
• 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: 11/19/2021

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 Expiration Date: 02/29/2024
• Device Model Number: 606-S255X
• Device Catalogue Number: 606S255X
• Device Lot Number: 30539966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 09/26/2021; 10/05/2021; 11/18/2021
• Supplement Dates FDA Received: 09/27/2021; 10/05/2021; 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 65 KG