MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER SELECT PLUS, 160CM X 5CM, 2 MARKERS; CATHETER, CONTINUOUS FLUSH

Catalog Number MC21160C2

Device Problem Peeled/Delaminated (1454)

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

Event Date 04/03/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: pc- (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / 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.A review of manufacturing documentation associated with this lot (30587326) 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 during a procedure, the physician felt like the inner coating of the 160cm x 5cm, 2 markers prowler select plus microcatheter (mc21160c2 / 30587326) was worn out.As a result, he could not move the indwelling devices a synchro2® 0.014¿ guidewire (stryker) and a chikai black 14 guidewire (asahi-intecc).He decided the take the microcatheter out of the patient¿s body because it was not possible to continue the procedure using the prowler select plus microcatheter.A phenom microcatheter (medtronic) was used and the procedure was successfully completed.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received the product analysis lab on 17-jun-2022.The return product is pending evaluation.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 procedure, the physician felt like the inner coating of the 160cm x 5cm, 2 markers prowler select plus microcatheter (mc21160c2 / 30587326) was worn out.As a result, he could not move the indwelling devices a synchro2® 0.014¿ guidewire (stryker) and a chikai black 14 guidewire (asahi-intecc).He decided the take the microcatheter out of the patient¿s body because it was not possible to continue the procedure using the prowler select plus microcatheter.A phenom microcatheter (medtronic) was used and the procedure was successfully completed.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 160cm x 5cm, 2 markers prowler select plus microcatheter was received.Visual inspection was performed and the device was observed to be in good, normal condition.Microscopic inspection was performed.Under magnification, the microcatheter was inspected along its entire body and the delamination condition was not found, residues of dry blood were found inside the lumen of the device and outside in the shaft.The device was flushed using a lab sample syringe.After that, a guide wire 0.018 inch lab sample was introduced into the received microcatheter and it advanced without noticeable issue (i.E., no friction was felt), only when the wire was advanced through the dried blood residues, slight resistance/friction was felt; this can be attributed to the residues of dried blood that could be noticed inside the device, which despite being flushed, they could not be shaken loose from the inner lumen of the microcatheter.The microcatheter was dissected on the portions where the resistance was felt, and it was confirmed that the resistance was caused by the dried blood residues, no delamination was found.The inner diameter (id) and outer diameter (od) were measured, and they were found to be within specifications.The reported issue in the complaint regarding the delamination of the coating on the device could not be confirmed since there were no functionality issues were noted on the device, and no contributing factors could be identified from the device that might have resulted in the issue encountered during the procedure.It is possible that continuous flush had not been maintained through the device, which resulted in the formation of blood residues observed.With the limited information available, this cannot be conclusively determined.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: before removing the catheter from the coil dispenser, flush the dispenser with heparinized saline through the luer connector fitting on the end of the coil dispenser; do not attempt to use infusion catheters without flushing first to hydrate the coating.Failure to do so may compromise the coating and lubricity of the catheter.A review of manufacturing documentation associated with this lot (30587326) 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.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.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, 160CM X 5CM, 2 MARKERS
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14177098
• MDR Text Key: 298986979
• Report Number: 3008114965-2022-00279
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: MC21160C2
• Device Lot Number: 30587326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2021
• 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
• Treatment: CHIKAI BLACK 14 GUIDEWIRE (ASAHI-INTECC).; SYNCHRO2® 0.014¿ GUIDEWIRE (STRYKER).