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

Model Number 8831661001

Device Problems Material Frayed (1262); Difficult to Remove (1528)

Patient Problem Hematoma (1884)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, after the catheter was inserted into the femoral vein for urgent hemodialysis connection, the catheter im plantation was completed, however, the physician was unable to advance the guide wire from the dialysis catheter inserted into the lumen of the venous vessel.The guidewire was stuck in the venous with the catheter when it was being removed; it was blocked, and the removal was not possible.After several attempts to eject the guide wire, it could not be removed.The doctor had to pull out the newly inserted catheter along with the guide wire.After removing the guide wire, significant damage (frayed) in one place was seen.All guide wire was removed from the patient vessel.It was not necessary to use x-ray or other procedure to check for retained pieces.They used strength or excessive force to take out/remove the guide wire but no tools used.The issue/damage with the guide wire was not noticed in the packaging.There was no resistance used when inserting the guidewire.The guide wire used was the one included in the kit.There was no damage to the device's box or packaging.The product/kit was still sealed upon receipt of the customer.Nothing unusual observed on the device prior to use.Flushing was done without problem prior to use.All the catheter kit was utilized with the device.No other defects/damages found on the product.There was no problem with the catheter's dimension and there was no occlusion.The catheter was not repaired, no leak, no tego utilized and no luer adapter issue.No cleaning agent used on the device.There was no blood loss and blood transfusion was not required.Big hematoma was noted in the place of catheter insertion and it was due to the event.Nothing special was needed and the hematoma has resolved by itself.There was no extended patient hospitalization.No other interventions or treatments provided to the patient as a result of this event.The product was replaced with the second catheter from the box with the same lot on the same day to resolve the issue and the new device was used successfully.The procedure was completed.The patient was stable.

Manufacturer Narrative

H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the guidewire was broken.It was reported that the guide wire was unable to be withdrawn and frayed.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
• MDR Report Key: 11342112
• MDR Text Key: 232386175
• Report Number: 3009211636-2021-00045
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521005235
• UDI-Public: 10884521005235
• Combination Product (y/n): N
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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: 8831661001
• Device Catalogue Number: 8831661001
• Device Lot Number: 2009200112
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 05/05/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR