MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER SELECT LPES; CATHETER, CONTINUOUS FLUSH

Catalog Number	606S155X
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # : (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3 - 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.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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 three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00828, 3008114965-2023-00827.
Event or Problem Description
As reported by the field, during a coil embolization, an orbit galaxy xtrasoft coil (640cx0406, 30692754) and an orbit galaxy xtrasoft coil (640cx3505, 30706309) became stuck into a prowler select lpes microcatheter (606s155x, 31041133).It was also noted that there is a thread inside the packing of the coil.The procedure was delayed by 30 minutes.The devices were removed easily without additional intervention.A new coil and microcatheter (mc) were used to compete the procedure successfully.There was no report of patient injury.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a coil embolization, an orbit galaxy xtrasoft coil (640cx0406, 30692754) and an orbit galaxy xtrasoft coil (640cx3505, 30706309) became stuck into a prowler select lpes microcatheter (606s155x, 31041133).It was also noted that there is a thread inside the packing of the coil.The procedure was delayed by 30 minutes.The devices were removed easily without additional intervention.A new coil and microcatheter (mc) were used to compete the procedure successfully.There was no report of patient injury.A non-sterile prowler select lpes microcatheter was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and no appearance of damages were observed.Microscopic inspection was performed along the body of the prowler, and no damages were found.The device was flushed with a laboratory sample syringe.After that, a 0.013-inch (0.03302 cm) guidewire lab sample was introduced into the received microcatheter, and was able to be advanced through the entire length of the microcatheter without noticeable resistance.The microcatheter was confirmed to be within specifications for the inner diameter (id) and outer diameter (od).A manufacturing record evaluation was performed for the finished device 31041133 number, and no non-conformances related to the malfunction were identified.The guide wire was able to pass through the entire length of the microcatheter without significant resistance, even through the hub.Additionally, no other damages were found on the microcatheter that could have contributed to the issue reported during the procedure.The customer complaint cannot be confirmed with the evidence available.It is possible that other clinical and procedural factors that cannot be replicated during the analysis may have contributed to the reported failure.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.The instructions for use (ifu) contain the following caution: 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 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.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).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.

• Brand Name: PROWLER SELECT LPES
• 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): 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 ; 3035526892
• MDR Report Key: 18121596
• Report Number: 3008114965-2023-00829
• Device Sequence Number: 18018152
• Product Code: KRA
• UDI-Device Identifier: 10886704028802
• UDI-Public: 10886704028802
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K021591
• 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
• Report Date (Section B): 01/12/2024

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: 04/30/2026
• Device Catalogue Number: 606S155X
• Device Lot Number: 31041133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 12/28/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/18/2023; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OG CMPLX XTRASOFT COIL 3.5X5; OG CMPLX XTRASOFT COIL 4X6
• Patient Sex: Unknown