MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 8831661001

Device Problem Material Deformation (2976)

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

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when the guide wire already in placed in the patient, during catheterization, the guide wire was found to be difficult to pass through the tip of the blue (venous) lumen, great resistance encountered, the front end of the catheter was curved, they straightened the front end of the catheter, pushed the guide wire firmly, it took a lot of effort to place the catheter through the guide wire, the guide wire was used successfully and the procedure was completed.The guide wire was not stuck.The guide wire used was the one included in the kit, no visual damage noted on the guide wire, the guide wire still intact, the guidewire was normal and had no problem.No other guide wire/product utilized.Nothing unusual observed on the device prior to use, flushing was done and the result was normal.The dimension of the catheter matched what was indicated on the label, there was no problem with the catheter's dimension, and no other defects/damages found on the catheter.The catheter was not repaired, there was no leak, no cleaning agent used on the device, tego was not utilized, and no luer adapter issue.The insertion site was cleaned iodine prior to product placement.There was no blood loss.No intervention/treatment required as a result of the event.There was no patient injury.

Manufacturer Narrative

Correction: rfr code this complaint has been reassessed and found not to be a reportable event.It was concluded that the event did not lead to a serious injury or have potential for serious injury with reoccurrence.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13839969
• MDR Text Key: 287545808
• Report Number: 3009211636-2022-00069
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521005235
• UDI-Public: 10884521005235
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8831661001
• Device Catalogue Number: 8831661001
• Device Lot Number: 1934400114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2022
• Date Device Manufactured: 01/07/2020
• 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