MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 125CM LARGE BORE 71 CATHETER; CATHETER, PERCUTANEOUS

Model Number	IC71125UG
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported during the preparation process for a thrombectomy procedure, the physician opened the device packaging for the complaint device, a 125cm large bore 71 catheter (ic71125ug / 30910652) and found the rotating male luer connector does not connect with the hemostasis valve female luer.The large bore catheter was not used in the patient.A new catheter was used to complete the procedure.There was no negative patient impact.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address was 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 (30910652) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 125cm large bore 71 catheter was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.The hub was found without damages (i.E., no cracks, no fractures, or deformations).The device was returned with the hemostasis valve.The hemostasis valve component was inspected under the microscope.Under magnification, no abnormalities were observed on it.The large bore catheter was connected to the hemostasis valve; they fit properly.There were no difficulties experienced during the connection.The issue regarding a catheter being unable to connect with the hemostasis valve to fit was not confirmed.Other circumstances or problems may have occurred during the use of the device that could not be replicated during the analysis.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30910652) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.Although no conclusion could be reached on the cause of the reported event, the instructions for use (ifu) contain the following precautions: carefully inspect all devices prior to use.Verify size, length, and condition are suitable for the specific procedure.Do not use a device that has been damaged in any way; replace with another large bore catheter.A damaged device may cause complications.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 06-may-2023.[additional information]: on 06-may-2023, additional information was received.The information indicated that another large bore catheter (ic71125ug) was used as replacement for the complaint device.Nothing unusual was noted on the system prior to use.The device was prepped in accordance with the instructions for use (ifu).There was no clinically significant delay in the procedure as a result of the reported issue.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 12-may-2023.The returned 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.

• Brand Name: 125CM LARGE BORE 71 CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS, INC.; 3260 executive way; miramar FL 33025
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 16882310
• Report Number: 3008114965-2023-00255
• Device Sequence Number: 7262328
• Product Code: DQY
• UDI-Device Identifier: 10886704082361
• UDI-Public: 10886704082361
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K191237
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2023

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: 01/31/2024
• Device Model Number: IC71125UG
• Device Catalogue Number: IC71125UG
• Device Lot Number: 30910652
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 05/06/2023; 05/12/2023; 05/19/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 05/08/2023; 05/12/2023; 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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
• Patient Sex: Unknown