MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED, COATED

Model Number 8888145044CP

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during catheter maintenance, when the blood tubes were connected to the dialysis machine, they immediately received a machine alarms about micro bubbles.Then a procedure for removing the micro bubbles was carried out and the dialysis treatment was started but they received the same alarm with micro bubbles again.It was also stated that the staff contacted a physician who decided to disconnect the patient from the dialysis treatment.The physician sees visible micro bubbles along the artery shaft.A vascular surgeon was instructed to arrange a time to remove the broken catheter and get a new catheter.It was mentioned that the treatment pressures from the past treatment was reviewed.Chlorhexidine was used as cleaning agent on the device and tego was not utilized.There was no leak and the insertion site was treated prior to product placement.The catheter was replaced.The treatment was not proceeded and was not completed.It was also noted that the patient was not responsible for any type of catheter maintenance and the cleaning agents was not switched over the life span of the catheter.There was no reported patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the cannula was cut near the cuff, the cuff was cut near the hub.The hub, extension tubes, clamps, sealing caps, blue and red luer adapters appeared intact.A functional evaluation found that there was enough cannula left to do a water bath test, the end was clamped and the catheter was submerged into a water bath.A syringe was used to inject air to observe leakage.No air bubbles were present.Both extensions were tested with acceptable results.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.Additionally, the investigation detected a unreported condition of cannula leak that has no relationship to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the cannula had been cut off near the cuff, the cuff had been cut off near the hub.Only the hub, extension tubes, clamps, sealing caps, blue and red luer adapters were received and appeared intact.The distal end of the cannula was not received for analysis.Since the entire device was not received for analysis we were not able to perform a complete investigation.A functional evaluation of the partial device was performed.The end was clamped and the catheter was submerged into a water bath.A syringe was used to inject air to observe leakage.No air bubbles were present.Both extensions were tested with acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9664847
• MDR Text Key: 194338194
• Report Number: 3009211636-2020-00032
• Device Sequence Number: 1
• Product Code: NYU
• UDI-Device Identifier: 10884521158085
• UDI-Public: 10884521158085
• Combination Product (y/n): N
• PMA/PMN Number: K123196
• 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: 06/01/2020

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: 05/15/2021
• Device Model Number: 8888145044CP
• Device Catalogue Number: 8888145044CP
• Device Lot Number: 1816400092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 05/18/2020
• Supplement Dates FDA Received: 03/26/2020; 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 53