MAUDE Adverse Event Report: COVIDIEN LLC PERMCATH; CATHETER, SUBCLAVIAN

Model Number	8817748001
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, during intubation of the catheter, the catheter was kinked and the catheter could not be placed.The catheter was not repaired, there was no leak, tego was not utilized, and there was no luer adapter issue.The product was replaced.There was no reported patient injury.
Event or Problem Description
According to the reporter, during intubation of the catheter, the catheter shaft was kinked and the catheter could not be placed.The catheter was not repaired, there was no leak, tego was not utilized, and there was no luer adapter issue.The patient was treated under local anesthesia.Betadine was the cleaning agent used on the device.No other defects or damages were found on the product.No other products were being utilized with the device.Nothing unusual was observed on the device prior to use.The insertion site was treated with betadine prior to product placement.Flushing was not done prior to use.The product was replaced with the same product id (identifier) and lot on the same day, and this resolved the issue and the treatment was completed.There was no blood loss.A blood transfusion was not required.No medical intervention or treatment was required due to the event.There was no reported patient injury.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted one catheter kit, with the cannula of the permcath being noticeably kinked.Aside from this kink, there appeared to be no abnormalities with the catheter or the additional items from the kit.(guidewire, sheath, needle etc.) it was reported that the catheter was kinked.The reported issue was 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 LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20257166
• Report Number: 1282497-2024-00397
• Device Sequence Number: 20836485
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2024

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: 03/10/2026
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 2103600122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 11/08/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 09/25/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 68 KG