MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENVOY DA, 6F, 105CM, MPD; PERCUTANEOUS CATHETER

Model Number	671-258-05D
Medical Device Problem Codes	Nonstandard Device (1420); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
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.(b)(6).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.Two photos accompanied were accompanied with the compliant file.Based on the visual analysis, the coating of the tip can be observed with a peeling condition, also, the braided mesh can be observed, the rest of the device cannot be observed in the photos provided.No other damages were observed in the photos.Based on the photos provided the customer complaint regarding the exposed braid wire was confirmed.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.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 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, during the prepping of an envoy da, 6f, 105cm, mpd (67125805d, 30460072) guide catheter, the physician observed uneven materials on the tip of the he catheter.The physician switched to a new device to complete the surgery.There was no patient injury reported as the device was not clinically used.A picture was provided.Additional information received indicated that there were no packaging issues.The inner pouch was securely sealed.The device had been stored and prepped as per the instructions for use (ifu).
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 the prepping of an envoy da, 6f, 105cm, mpd (67125805d, 30460072) guide catheter, the physician observed uneven materials on the tip of the he catheter.The physician switched to a new device to complete the surgery.There was no patient injury reported as the device was not clinically used.A picture was provided.Additional information received indicated that there were no packaging issues.The inner pouch was securely sealed.The device had been stored and prepped as per the instructions for use (ifu).Two photos accompanied the compliant file.In them, the coating of the tip can be observed to be uneven, exposing the internal mesh.The device does not look stretched; however, the coating seems to be peeling.A non-sterile envoy da, 6f, 105cm, mpd was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and the envoy catheter was found with five (5) kinked conditions at 13 cm, 34 cm, 55 cm, 73 cm, and 75 cm; this was measured from the proximal end of the device.Also, the coating of the tip can be observed to be uneven, exposing the internal mesh since the coating was peeling as observed in the photos provided.No other damages or anomalies were observed on the envoy catheter.The inner diameter (id) and outer diameter (od) were measured and found to be within specifications.The kinked conditions observed during the visual inspection are suspected to be related to the handling of the device/package during the shipping or decontamination process, since there is no indication that the catheter has been kinked at the preparation time.The device was reviewed by the manufacturing team.During the manufacturing review, it was revealed that the coat has some residues of unknown fibers along the brite tip.A sample of the catheter coating was submitted to structural analysis- fourier transform infrared spectroscopy (ft-ir) for detailed inspection.The ft-ir results revealed an advanced degradation process on plastic resin, presumably caused by material oxidation from an external source such as sunlight, temperature, humidity, photooxidation, etc.However, the exact mechanism of the degradation cannot be ascertained.Based on the manufacturing investigation performed, it was concluded that the unit was released from the manufacturing site in good condition and 100% functional per visual inspections during the manufacturing process.The damage observed in the unit was caused by exposing the unit to an external agent, such as a corrosive chemical, or an external source, such as sunlight, high temperature, or humidity.Although the complaint documented that no packaging issues were observed and that the inner pouch was noted securely sealed, it is possible that the handling of the device, once it is removed from the protective box, may have contributed to the damage.Other factors not described within the information available may have contributed to the encountered issue.Analysis of production records for lot 30460072 confirmed that all units presented no issues during the manufacturing or inspection processes related to the reported complaint.The verification for environmental temperature and relative humidity before and after the coating process was confirmed to be within specifications.There were no nonconformances related to the device manufacture or inspection.The customer complaint related to the exposed braid wire and the coating unevenness was confirmed based on the appearance of the returned device; however, there is no indication that the issue reported in the complaint is a result of a manufacturing defect.It should be noted that product failure is multifactorial.The instructions for use contain the following precaution: do not use a catheter that has been damaged in any way.If damage is detected, replace it with another envoy guiding catheter that is not damaged.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: ENVOY DA, 6F, 105CM, MPD
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (MIRAMAR); 3260 executive way; miramar FL 33025
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14625775
• Report Number: 3008114965-2022-00406
• Device Sequence Number: 4455725
• Product Code: DQY
• UDI-Device Identifier: 10878528000676
• UDI-Public: 10878528000676
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2022

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: 08/31/2023
• Device Model Number: 671-258-05D
• Device Catalogue Number: 67125805D
• Device Lot Number: 30460072
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 11/18/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/26/2022; 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• 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