MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	8888135161
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
According to the reporter, during insertion, the guidewire could not be implanted and passed through the puncture needle tip after successful needle insertion.The guide wire was stuck.The catheter was not repaired, there was no leak, no cleaning agent used on the device, tego was not utilized, no luer adapter issue and the insertion site was not treated prior to product placement.No tools used to remove the guide wire.No excessive force required to remove the guide wire.The guide wire was not frayed/coiled/unraveled.The guide wire was still intact.No resistance noted when inserting the guide wire.No visible defect/damage noted with the needle.The guide wire and needle used were the ones included in the kit.The dimension of the needle and the guide wire matched what was indicated on the label.Nothing unusual observed on the device prior to use.Flushing was done prior to use and the result was normal.No other products being utilized with the device.No other defects/damages found on the product.The guide wire and needle were withdrawn together.Implantation was successful after replacement of package with the same product id (identifier) and batch number on the same day and the procedure was completed.There was no blood loss.No intervention/treatment required as a result of the event.There was no patient injury.
Additional 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 or Problem Description
According to the reporter, during insertion, the guidewire could not be implanted and passed through the puncture needle tip after successful needle insertion.The guide wire was stuck.The catheter was not repaired, there was no leak, no cleaning agent used on the device, tego was not utilized, no luer adapter issue and the insertion site was not treated prior to product placement.No tools used to remove the guide wire.No excessive force required to remove the guide wire.The guide wire was not frayed/coiled/unraveled.The guide wire was still intact.No visible defect/damage noted with the needle.The guide wire and needle used were the ones included in the kit.The dimension of the needle and the guide wire matched what was indicated on the label.Nothing unusual observed on the device prior to use.Flushing was done prior to use and the result was normal.No other products being utilized with the device.No other defects/damages found on the product.The guide wire and needle were withdrawn together.Implantation was successful after replacement of package with the same product id (identifier) and batch number on the same day and the procedure was completed.There was no blood loss.No intervention/treatment required as a result of the event.There was no patient injury.
Event or Problem Description
According to the reporter, during insertion, the guidewire could not be implanted and passed through the puncture needle tip after successful needle insertion.The guide wire was stuck.The catheter was not repaired, there was no leak, no cleaning agent used on the device, tego was not utilized, no luer adapter issue and the insertion site was not treated prior to product placement.No tools used to remove the guide wire.No excessive force required to remove the guide wire.The guide wire was not frayed/coiled/unraveled.The guide wire was still intact.No visible defect/damage noted with the needle.The guide wire and needle used were the ones included in the kit.The dimension of the needle and the guide wire matched what was indicated on the label.Nothing unusual observed on the device prior to use.Flushing was done prior to use and the result was normal.No other products being utilized with the device.No other defects/damages found on the product.The guide wire and needle were withdrawn together.Implantation was successful afterreplacement of package with the same product id (identifier) and batch number on the same day and the procedure was completed.There was no blood loss.No intervention/treatment required as a result of the event.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted one catheter and a guidewire.The guidewire was bent in places supporting the customer complaint of difficulty to remove from the puncture needle.It was reported that the guide wire was unable to be withdrawn.The reported issue was 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
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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: 15382325
• Report Number: 3009211636-2022-00270
• Device Sequence Number: 5797492
• Product Code: MPB
• UDI-Device Identifier: 10884521006355
• UDI-Public: 10884521006355
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2026
• Device Model Number: 8888135161
• Device Catalogue Number: 8888135161
• Device Lot Number: 2113300202
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 04/11/2023; 04/21/2023
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 04/17/2023; 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• 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