MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL IC 71, 132 CM, CE, ASP. IND.; CATHETER, PERCUTANEOUS

Catalog Number	IC71132CA
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, an embovac catheter (ic71132ca, 31098757) was kinked from the distal tip zone.No additional information is available.Based on the product analysis of the device received, the body/shaft was fractured.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The body/shaft of the product was fractured, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.One photo was provided alongside the complaint, in which there are visible compressions and kinks in the distal portion of the catheter.The rest of the device is not visible in the picture and no other damages can be observed.A non-sterile ic 71, 132 cm, ce, asp.Ind.Was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and two stretched sections were found in the distal portion of the catheter, the first was found from 6cm until 9cm and the second from 13cm until 19cm.Also, as seen in the provided picture multiple compressions and kinks were found in these sections.All measurements were taken from the distal end of the device.Further inspection on the microscope revealed that as a result of the severity of the stretching the internal braided mesh was exposed.The issues reported regarding a catheter being kinked confirmed based on the damages found on the received device; however, factors not described in the information provided, such as patient¿s anatomy, device manipulation, and operator¿s technique, may have contributed to the issue encountered.According to the risk documentation a damaged catheter is a potential issue that can occur during withdrawal of catheter.With the limited information available, a conclusive cause cannot be determined, however, given the broad sequence of events, there is no indication that the issue reported in the complaint is related to a manufacturing issue.A manufacturing record evaluation was performed for the finished device 31098757 number, and no non-conformances related to the malfunction were identified.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages such as catheter stretching and kinking from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use contain the following precaution: exercise care in handling the intermediate catheter to reduce the chance of accidental damage.Multiple attempts to obtain additional event information have been unsuccessful.If additional information is received at a later date, the file will be updated accordingly.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.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.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.

• Brand Name: IC 71, 132 CM, CE, ASP. IND.
• 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. (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: 20302773
• Report Number: 3008114965-2024-00944
• Device Sequence Number: 21049383
• Product Code: DQY
• UDI-Device Identifier: 10886704082378
• UDI-Public: (01)10886704082378(17)241130(10)31098757
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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: 11/30/2024
• Device Catalogue Number: IC71132CA
• Device Lot Number: 31098757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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