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

Model Number 8813793013

Device Problem Difficult to Remove (1528)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 8813793013 11.5fr 19.5cm mahka kit wce (lot#: 2122900207).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.

Event Description

According to the reporter, when inserting guide wire into the catheter at the catheter tip, it got stuck and did not go through either end.The catheter was not repaired.There was no leak.There was no luer adapter issue.They only opened two catheters and the health professional decided not to use the catheters.There was no patient involvement.

Event Description

According to the reporter, when inserting guide wire into the 2 catheters at the catheter tip, it got stuck and did not go through e ither end.The catheter was not repaired.There was no leak.There was no luer adapter issue.They only opened two catheters and the health professional decided not to use the catheters.It was later stated that it was a placement error on the part of health profe ssionals.The distributor stated that the failure was possibly due to a lack of expertise in the placement of the catheter by health personnel.The products did not have contact with patient.The product was not contaminated with biohazards.The product was not sa nitized or cleaned.There was no patient involvement.

Manufacturer Narrative

Additional information: b5, g3 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.

Event Description

According to the reporter, when inserting guide wire into the two catheters at the catheter tip, it got stuck and did not go through either end.The catheter was not repaired.There was no leak.There was no luer adapter issue.They only opened two catheters and the health professional decided not to use the catheters.It was later stated that it was a placement error on the part of health professionals.The products did not have contact with patient.The product was not contaminated with biohazards.The product was not sanitized or cleaned.There was no patient involvement.

Manufacturer Narrative

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.

Event Description

According to the reporter, they only opened two catheters and when inserting guide wire into the 2 catheters at the catheters tip, it got stuck and did not go through either end.The catheter was not repaired.There was no leak.There was no luer adapter issue.It was later stated that their research was conducted and noted that it was a placement error on the part of health professionals.It was also stated that the distributor mentioned that the failure was possibly due to a lack of expertise in the placement of the catheter by health personnel.The product was not contaminated with biohazards.The product was not sanitized or cleaned.The health professional decided not to use the catheters.There was no patient involvement.

Manufacturer Narrative

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 55112 ; 7635265677
• MDR Report Key: 16195631
• MDR Text Key: 308866675
• Report Number: 3009211636-2023-00029
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004832
• UDI-Public: 10884521004832
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813793013
• Device Catalogue Number: 8813793013
• Device Lot Number: 2122900207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2023
• Date Device Manufactured: 12/21/2021
• 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
• Treatment: SEE NOTE ON H10