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

Model Number 8888221220

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the returned photos noted: the first image depicts the j hook of the guide wire protruding through the slot at the distal end of the catheter.The second image depicts the guide wire protruding from the side hole and making a loop.The third image depicts the surgeon holding the catheter by the distal end of the cannula.The j hook of the guide wire is protruding through the side hole, the catheter is bloodies and shows signs of use.The fourth image depicts a close-up view of the surgeon holding the distal end of the catheter cannula, the j hook of the guide wire is protruding through the side hole.Without the physical device functional evaluations are precluded.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.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during procedure, they said that the guidewire did not progress through the lumen of the catheter exiting through the lateral groove of the venous lumen.The procedure was for a catheter replacement using the guidewire, for the catheter that was already implanted in the patient, it was also mentioned that it was necessary to remove the catheter completely to check why the guidewire did not progress.There were patient symptoms or complications associated with the event because the catheter had to be removed along with the guidewire.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.This event did not lead to extend patient's hospitalization time, but in the procedure time, due to the difficulty encountered with the guidewire.It was also noted that the device was replaced by another manufacturer.Catheter was not repaired and there was no leak.Tego was not utilized and there was no luer adapter issue, the insertion site was not treated prior to product placement and the product was replaced by another manufacturer.There was no reported patient injury.

Event Description

According to the reporter, during procedure, they said that the guidewire did not progress through the lumen of the catheter exiting through the lateral groove of the venous lumen.The procedure was for a catheter replacement using the guidewire, for the catheter that was already implanted in the patient, they said that it was necessary to remove the catheter completely to check why the guidewire did not progress.The implanted catheter to the patient was removed and a new puncture was needed in another location.Normal flushing was done before use and there was nothing unusual observed to the product during visual inspection, after removing the catheter, the guidewire that was used in the kit was emerged without difficulty and when it was removed it was still intact but located outside the catheter according to the images sent.It was said that x-ray was not performed after the procedure.There were no patient symptoms or complications seen by the patient due to the event.This event did not lead to extend patient's hospitalization time, but there was an increase in surgical time.There was no blood loss and blood transfusion were not required, the device was replaced by another manufacturer.Catheter was not repaired and there was no leak.Tego was not utilized and there was no luer adapter issue, the insertion site was not treated prior to product placement and the product was replaced by another manufacturer.There was no reported patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the returned photos noted: the first image depicts the j hook of the guide wire protruding through the slot at the distal end of the catheter.The second image depicts the guide wire protruding from the side hole and making a loop.The third image depicts the surgeon holding the catheter by the distal end of the cannula.The j hook of the guide wire is protruding through the side hole, the catheter is bloodies and shows signs of use.The fourth image depicts a close-up view of the surgeon holding the distal end of the catheter cannula, the j hook of the guide wire is protruding through the side hole.Without the physical device functional evaluations are precluded.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: ULTRAFLO
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10031542
• MDR Text Key: 193693029
• Report Number: 3009211636-2020-00093
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521125735
• UDI-Public: 10884521125735
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

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: 06/21/2023
• Device Model Number: 8888221220
• Device Catalogue Number: 8888221220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1