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

Model Number 8813817009

Device Problems Product Quality Problem (1506); Difficult to Remove (1528)

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

Event Date 05/05/2022

Event Type  malfunction  

Event Description

According to the reporter, during procedure, while retrieving the guide wire from the needle, it got kinked and became difficult to take it out (it was stuck).Nothing unusual was observed on the device prior to use (packaging was discarded once opened).The catheter was not repaired and had no leak.Chlorohexidine solution 2% was the cleaning agent used on the device.There was no luer adapter issue.No damage was noted on the guidewire like frayed, coiled, unravel and had no broken pieces.The guidewire was provided with the kit being used.No dimension issue was noted.No other products were being utilized with the device.Flushing was done and there was no issue with the catheter.No excessive force was used during insertion/removal but there was a resistance noted during withdrawal.There was no blood loss and no blood transfusion was required.The patient had no medical intervention/treatment due to the event.It was said that the guidewire was removed from the patient together with the needle but they still managed and succeeded to take out the guidewire as it came out after many attempts of withdrawal.Procedure was said to be not completed.There was no reported patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: d9, g1, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the guidewire was kinked and the guidewire had small blood clots stuck to it.Functionally, the guidewire was cleaned and straightened and fed into a representative needle.The guidewire was able to be passed through the needle without difficulty.It was reported that the guide wire was unable to be withdrawn, and there was a guide wire issue.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: justin ellis ; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 14550358
• MDR Text Key: 293613092
• Report Number: 3009211636-2022-00135
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004917
• UDI-Public: 10884521004917
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

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
• Device Operator: Health Professional
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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