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

Model Number 8888211416

Device Problem Break (1069)

Patient Problems Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the guide wire uncoiled during insertion.It was noted that the tip of the guide wire broke off in the insertion needle when retracted by the physician.The catheter was not repaired, there was no leak, tego was not utilized, and there was no luer adapter issue.Fluoroscopy was used to check if any guide wire pieces were left in the patient and it was stated to be negative.The kit was replaced by another product from a different manufacturer.There were no patient symptoms or complications noted associated with the event.The patient was reported to be deceased.The patient's death was reported not to be related to the alleged complaint.

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 Description

According to the reporter, the guide wire uncoiled during insertion.It was noted that the tip of the guide wire broke off in the insertion needle when retracted by the physician.The catheter was not repaired, there was no leak, tego was not utilized, and there was no luer adapter issue.Fluoroscopy was used to check if any guide wire pieces were left in the patient and it was stated to be negative.The kit was replaced by another product from a different manufacturer.There were no patient symptoms or complications noted associated with the event.The patient was reported to be alive at the time of the event and was later reported to be deceased from complications not related to the incident.The patient's death was reported not to be related to the alleged complaint.

• Brand Name: MAHURKAR ELITE
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9540472
• MDR Text Key: 173528559
• Report Number: 3009211636-2020-00004
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521126015
• UDI-Public: 10884521126015
• Combination Product (y/n): N
• PMA/PMN Number: K120674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2020
• Device Model Number: 8888211416
• Device Catalogue Number: 8888211416
• Device Lot Number: 1835100092
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR