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

Model Number 8888135241

Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2020

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 performing femoral vein catheterization after a routine disinfection.The puncture needle was punctured, then the guide wire was inserted, but resistance was felt.When the guide wire was retrieved, it could not be removed from the puncture needle, and could only be pulled out with the guide wire, and the puncture needle.After the guide wire was withdrawn, it was found that the guide wire was partially kinked.A new catheter was used, and able to place smoothly.Normal saline flush was used as cleaning agent on the device.The catheter was not repaired.There was no leak, no tego utilized, and no luer adapter issue.There was no patient symptoms, or complications associated with the event.There was no patient injury.

Event Description

According to the reporter, after a routine disinfection while performing femoral vein catheterization, when the puncture needle was able to be punctured, resistance was felt when the guide wire was inserted.The guide wire together with the puncture needle was moved out of the body.When the guide wire was retrieved, it could not be removed from the puncture needle so the guide wire was forcibly pulled out.It was stated that the patient was under local anesthesia.There was no tools used when trying to remove the guide wire.After the guide wire was withdrawn, it was found that the guide wire was partially kinked and not frayed or coiled.A new catheter was used and able to place smoothly.It was stated that the procedure was completed.There was a blood loss of 1-2 milliliters but no blood transfusion required.Normal saline flush was used as cleaning agent on the device.It was stated that the guide wire was not kinked prior to use and catheter and accessories were flushed and infiltrated.The catheter was not repaired.There was no lea k, no tego utilized, and no luer adapter issue.There was no intervention/treatment performed and no x-ray or other procedures performed.There was no packaging damage, no other defects/damages found on the device prior to use and nothing unusual observed on the device prior to use.The guide wire used was the one provided in the kit.There was no patient symptoms or complications associated with the event.There was no patient injury.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.Visual inspection noted the surgeon trying to remove the guide wire from the introducer needle, being pulled and becoming unraveled.It was reported that the guide wire was unable to be withdrawn and there was a needle 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.

Manufacturer Narrative

H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the guide wire was bent about midway, and the catheter appeared intact.Functionally, the catheter was submerged into a water bath.The ends were clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present.Both extensions were tested with acceptable results.The guide wire was inserted into both lumen, no occlusion noted.It was reported that the guide wire was unable to be withdrawn, and there was a needle issue.The reported issues could not be 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, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10688817
• MDR Text Key: 211645264
• Report Number: 3009211636-2020-00252
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006539
• UDI-Public: 10884521006539
• Combination Product (y/n): N
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2021

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: 8888135241
• Device Catalogue Number: 8888135241
• Device Lot Number: 1926700116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 10/12/2020; 01/07/2021
• Supplement Dates FDA Received: 10/30/2020; 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR