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

Model Number 671-258-05D

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, gender, weight, race, and ethnicity were not provided.Reporter phone: the initial reporter phone: (b)(6).The initial reporter email address was not reported.Conclusion: the healthcare professional reported that during a procedure, the envoy da, 6f, 105cm mpd distal access catheter (67125805d / 30446673) was used and the physician attempted to take an angiogram to observe its position, but the tip of the catheter could not be displayed.The physician retracted the catheter and replaced it to complete the procedure.There was no report of any patient adverse event or complication.The complaint device is not available to be returned for evaluation and analysis.On 28-jun 2022, additional information was received.The information indicated that the target of the procedure was on the c3 segment of the internal carotid artery (ica).The wire of the device was visible.The reported issue did not result in inadequate positioning of the concomitant device.It was replaced by another envoy da, 6f, 105cm mpd distal access catheter (67125805d).The reported issue did not result in any clinically significant delay in the procedure.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30446673) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the product available to be returned for evaluation and analysis.The reported issue documented in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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.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.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.

Event Description

The healthcare professional reported that during a procedure, the envoy da, 6f, 105cm mpd distal access catheter (67125805d / 30446673) was used and the physician attempted to take an angiogram to observe its position, but the tip of the catheter could not be displayed.The physician retracted the catheter and replaced it to complete the procedure.There was no report of any patient adverse event or complication.The complaint device is not available to be returned for evaluation and analysis.On (b)(6) 2022, additional information was received.The information indicated that the target of the procedure was on the c3 segment of the internal carotid artery (ica).The wire of the device was visible.The reported issue did not result in inadequate positioning of the concomitant device.It was replaced by another envoy da, 6f, 105cm mpd distal access catheter (67125805d).The reported issue did not result in any clinically significant delay in the procedure.

• Brand Name: ENVOY DA, 6F, 105CM, MPD
• Type of Device: 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 ; 646591-798
• MDR Report Key: 14960258
• MDR Text Key: 301469622
• Report Number: 3008114965-2022-00454
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10878528000676
• UDI-Public: 10878528000676
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 671-258-05D
• Device Catalogue Number: 67125805D
• Device Lot Number: 30446673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1