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

Model Number 8888135191

Device Problems Break (1069); Material Puncture/Hole (1504); Difficult to Advance (2920)

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

Event Date 10/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient was admitted to the hospital for acute myocardial infarction and acute renal failure.The patient underwent catheterization (first set) of the left femoral vein and the procedure was smooth.During the high-pressure irrigation before continuous renal replacement therapy (crrt), the blue venous end (on the extension tube, near the adapter) of the catheter was leaking.It was mentioned that there was also a leak at the exit site.The clamp was moved periodically.The catheter was extubated and another set of catheter (second set) of the same product was opened.After opening the outer package, it was found that the front end of the dilator was bent into a hook shape and it could not be inserted in to the blood vessel.The dilator was the one included in the kit of the second set of catheter.Another set of catheter (third set) of the same product was opened and during the catheterization process, the guide wire was bent an could not be inserted smoothly.There was no problem with the third catheter's dimension and there was no occlusion.The guide wire that was bent was the one included in the kit of the third set of catheter.All p ieces were accounted for when the guide wire was removed.To resolve the issue, the guide wire of the second sent of catheter was used while using the third set of catheter and the operation was successfully completed.The catheters were not repaired and no cleaning agents were on the catheters.Tego was not utilized and there were no luer adapter issues.The insertion site was treated with iodophor disinfection prior to product placement.There was no damage to the any of the devices' box and packaging.The products/kits were still sealed upon receipt.Prior to use, there was nothing unusual observed on the devices and flushing was not done.There were no other products being utilized with the device.There was no blood loss and no intervention was required as a result of the event.There was no patient injury.

Event Description

According to the reporter, the patient was admitted to the hospital for acute myocardial infarction and acute renal failure.The patient underwent catheterization (first set) of the left femoral vein and the procedure was smooth.During the high-pressure irrigation before continuous renal replacement therapy (crrt), the blue venous end (on the extension tube, near the adapter) of the catheter was leaking.It was mentioned that there was also a leak at the exit site.The clamp was moved periodically.The catheter was extubated, and another set of catheter (second set) of the same product was opened.After opening the outer package, it was found that the front end of the dilator was bent into a hook shape, and it could not be inserted in to the blood vessel.The dilator was the one included in the kit of the second set of catheter.Another set of catheter (third set) of the same product was opened and during the catheterization process, the guide wire was bent and could not be inserted smoothly.There was no problem with the third catheter's dimension, and there was no occlusion.The guide wire that was bent was the one included in the kit of the third set of catheter.All pieces were accounted for when the guide wire was removed.To resolve the issue, the guide wire of the second sent of catheter was used while using the third set of catheter and the operation was successfully completed.The catheters were not repaired and no cleaning agents were on the catheters.Tego was not utilized and there were no luer adapter issues.The insertion site was treated with iodophor disinfection prior to product placement.There was no damage to the any of the devices' box and packaging.The products/kits were still sealed upon receipt.Prior to use, there was nothing unusual observed on the devices and flushing was not done.There were no other products being utilized with the device.There was no blood loss, and no intervention was required as a result of the event.There was no patient injury.

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.

Manufacturer Narrative

Additional information: d8, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.A video was also provided.Visual inspection noted there was a disconnection in the extension tube which led to a leak and the guidewire was frayed, broken, or kinked.It was reported that there was a leak on the extension tube and a guide wire issue.The reported issues were confirmed.The most likely cause could not be established from the information available.It was also reported that there was an issue with the dilator.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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 and a photo were available for evaluation.A video was also provided.Visual inspection noted there was a cut in the extension tube which led to a leak.Functionally, the distal end of the cannula was clamped and a water bath test was performed, air bubbles were detected near the adapter extension tube connection on the blue port side.A small hole was observed.It was reported that there was a leak on the extension tube, an issue with the dilator, and a guide wire issue.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when contact is made with a sharp surgical instrument during clinical application.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: 10740874
• MDR Text Key: 213219870
• Report Number: 3009211636-2020-00263
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• 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,Followup
• Report Date: 03/03/2021

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 Expiration Date: 05/28/2024
• Device Model Number: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 1917200313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 10/28/2020; 11/19/2020; 02/09/2021
• Supplement Dates FDA Received: 11/10/2020; 12/10/2020; 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR