MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERMCATH; CATHETER, SUBCLAVIAN

Model Number 8817748001

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient needed to indwell a hemodialysis catheter due to renal failure.After catheterization, it was found that there was a fissure and leakage in the silicone tube at the lower end of the catheter (near the cuff).The catheter was not repaired and iodophor was the cleaning agent used the he device.Tego was not utilized and there was no luer adapter issue.Prior to use, there was no abnormality observed on the device and the catheter was pre-flushed and had a moist in its result.There were no other products utilized with the device and the patient was treated under local anesthesia.Sterile gauze was the wound dressing used which also did not include any cleaning agents or antibacterial properties.The cleaning agent was not allowed to dry thoroughly prior to dressing the area and the cleaning agents were never mixed.The catheter has not been cleaned with sepsiderm and the patient did not use any type of cleaner or antibiotic on the catheter.They changed to a new hemodialysis catheter from another manufacturer to resolve the issue and the procedure was completed.There was 5 ml of blood loss and blood transfusion was not required.There was no treatment.Treatment required as a result of the event.There was no reported patient outcome.

Manufacturer Narrative

Additional information: d9, g1, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the cannula had a break near the cuff.It was reported that there was a leak on the catheter shaft.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: a contact with sharp objects should be avoided.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: PERMCATH
• Type of Device: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 13866329
• MDR Text Key: 287803448
• Report Number: 3009211636-2022-00073
• Device Sequence Number: 1
• Product Code: LFJ
• UDI-Device Identifier: 10884521009868
• UDI-Public: 10884521009868
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K871942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 2009300097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian