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

Model Number 8813793013

Device Problems Material Frayed (1262); Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem Hematoma (1884)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, intra-operatively, the patient entered the operating room under general anesthesia to remove and replace a dysfunctional peritoneal catheter with the product.In the first attempt, right internal jugular vein was the first chosen insertion site however as they tried to place the catheter, it caused a bruise and it was corrected by pressing with fingers on the puncture site to stop the bleeding and to decrease the bruise.It was decided to change to left internal jugular vein and the catheter was introduced however only the venous (blue) line had a return flow.A request was made for rx de torax (chest x-ray) to see the position of the tip and detected the tip of the catheter was kinked.It was decided to end the procedure and request support for angiology to remove the product.It was also mentioned that guide wire had became entangled/kinked/bent in the tip (the segment that enters to the intraluminal space of the catheter) during the access placement.There was difficulty encountered while removing the guide w ire.It was stated that the guidewire and catheter were removed from the patient at the same time.The guide wire from the kit was used/utilized.When the guidewire was removed, the device was not intact but no parts of the guide wire left into the patient.Visual inspection was not done.There was blood loss of 50 ml and blood transfusion was not required.The event did not lead to patient hospitalization.Catheter was not repaired, there was no leak and there was no luer adapter issue.Opside was utilized with the device.Clorhexidine was used on the device as cleaning agent and chlorhexidine (chloraprep) was used to clean the patient's skin prior to incision.As the procedure was cancelled and a temporary catheter was no longer placed, replacement was rescheduled for another day to be able to place a new product.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 of the image showed the catheter being held so the cannula was facing up.The luer adapters, extension tubes, clamps, hub, suture wing and cannula were in view.It was reported that the guide wire was unable to be withdrawn, the catheter was kinked, and the guide wire was unraveled.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.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
• MDR Report Key: 10545564
• MDR Text Key: 207300304
• Report Number: 3009211636-2020-00228
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004832
• UDI-Public: 10884521004832
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2024
• Device Model Number: 8813793013
• Device Catalogue Number: 8813793013
• Device Lot Number: 1906000130
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR