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

Model Number	8817748001
Medical Device Problem Codes	Product Quality Problem (1506); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
According to the reporter, during catheterization surgery, the guide wire within the kit had been used, was stuck in the needle tip upon removal or withdrawal, and it was worn.However, it was stated that the guide wire and the needle did not need to be removed from the patient simultaneously due to the alleged defect, as the guidewire was removed alone.The guide wire was removed by hand, and no tools were used.It was also stated that the guide wire was still intact and slightly bent when it was removed, but it was not bent and was not worn when unpacking and prior to insertion into the puncture needle.There was nothing unusual observed on the device prior to use.There was no problem with the catheter's dimension.There was no leak and no luer adapter issue.Besides the reported issue, there were no other visible defects/damages found on the product.Flushing was done prior to use with a normal result.Tego was not utilized, and there were no other products utilized with the device.There was no excessive force used on the device.Iod ophor was the cleaning agent used on the device.The insertion site was treated with iodophor prior to product placement.The catheter was not repaired.As a remedial action, the reported product was replaced by a new product to continue the procedure, and the pro cedure was completed.There was a blood loss of about 3 milliliters (ml), and a blood transfusion was not required.There was no medical intervention/treatment required due to the event.There was no reported patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted one kit.The guidewire was stuck in the puncture needle, and was unraveled from excessive force.The returned guidewire was removed from the needle, and a representative guidewire was inserted into the needle without sticking.The j tip of the returned guidewire was bloody, and some white fibers were caught in the unraveled portion of the guidewire.It was reported that the guide wire was frayed, coiled or unravelled, and there was a guide wire issue.The reported issues were 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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PERMCATH
• Common Device Name: 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: 18115020
• Report Number: 3009211636-2023-00305
• Device Sequence Number: 7540794
• Product Code: LFJ
• UDI-Device Identifier: 10884521009868
• UDI-Public: 10884521009868
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 2002100132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male