MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER-14 DUAL MARKER; CATHETER, CONTINUOUS FLUSH

Model Number	606-151FX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during an intracranial coil embolization, a cerenovus coil was placed without trouble and then a micrusframe14 7mmx11cm coil (mfr140711, lot unknown) was being used as the second coil.However, the coil could not be advanced within preshaped prowler14 microcatheter (606151fx, lot unknown).Thus, the coil and the mc had to be withdrawn.A new cerenovus coil was used with a new mc and the procedure was completed.Additional information received indicated that the coil did not appear damaged, it could simply not be pushed any further within the microcatheter.After advancement was not possible, withdrawal was tried but also impossible, the coil got stuck.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.No excessive force was applied to the device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Lot: the lot number 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00024.
Additional Manufacturer Narrative
Product complaint #(b)(4).The lot number of the involved product and the expiration date were inadvertently omitted on the initial medwatch report.Section d1: brand name: prowler-14 dual marker.Section d4: unique identifier (udi): (b)(4).
Additional Manufacturer Narrative
Product complaint #(b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during an intracranial coil embolization, a cerenovus coil was placed without trouble and then a micrusframe14 7mmx11cm coil (mfr140711, l17027) was being used as the second coil.However, the coil could not be advanced within preshaped prowler14 microcatheter (606151fx, 30490149).Thus, the coil and the mc had to be withdrawn.A new cerenovus coil was used with a new mc and the procedure was completed.Additional information received indicated that the coil did not appear damaged, it could simply not be pushed any further within the microcatheter.After advancement was not possible, withdrawal was tried but also impossible, the coil got stuck.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.No excessive force was applied to the device.A non-sterile prowler-14 dual marker unit was received in a pouch.Upon arrival it was noticed that microcatheter was accordionated on its distal part and embolic coil micrusframe14 7mmx11cm was stuck inside.Further inspection revealed a bump at 44 inches from the proximal end of the microcatheter.Device was dissected and core wire of the micrusframe14 7mmx11cm was found to be bent inside of the microcatheter.A manufacturing record evaluation (mre) was performed, and no non-conformances related to the complaint were found during the review.The product was returned to cerenovus for evaluation.Upon arrival, prowler-14 dual marker was visually inspected, and it was found to be accordionated at its distal portion.Additionally, it was noticed that micrusframe14 7mmx11cm was still stuck inside the microcatheter.A bump was noticed at 44 inches from the proximal end of the microcatheter and a dissection was performed.The core wire from the micrusframe14 7mmx11cm was found bent inside the microcatheter causing the obstruction.The customer complaint was confirmed based on the findings observed, however root cause could not be determined.Since the failure occurred during the implantation of the second coil using this microcatheter, there might have been intraprocedural factors that contributed to the failure mode.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following precautions: do not use a catheter that has been damaged in any way.Damaged catheters may rupture causing vessel damage or tip detachment during the procedure.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.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 guidewires a system.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 to identify statistical signals for consideration of further correction action.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.

• Brand Name: PROWLER-14 DUAL MARKER
• Common Device Name: 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 ; 9497898687
• MDR Report Key: 13235370
• Report Number: 3008114965-2022-00025
• Device Sequence Number: 4555172
• Product Code: KRA
• UDI-Device Identifier: 10886704028598
• UDI-Public: 10886704028598
• Combination Product (Y/N): N
• PMA/510(K) Number: K972518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 606-151FX
• Device Catalogue Number: 606151X
• Device Lot Number: 30490149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 01/13/2022; 01/24/2022; 02/27/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 01/13/2022; 02/09/2022; 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICRUSFRAME14 7MMX11CM.
• Patient Sex: Unknown