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

Model Number 8888145040P

Device Problem Obstruction of Flow (2423)

Patient Problems Air Embolism (1697); Dyspnea (1816); Paralysis (1997); Confusion/ Disorientation (2553); Unintended Radiation Exposure (4565); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/10/2023

Event Type  Injury  

Event Description

According to the reporter, the patient's right chest catheter line was attempted to be accessed in an outpatient hospital appointment (patient room).The patient reported to the ambulatory unit for an appointment for a blood draw, the rn (registered nurse) flushed easily the red lumen with a 10ml normal saline syringe, however, when the rn used an empty 5 ml syringe to pull the blood sample off the central line, only 1 ml saline and a flash of blood returned into the syringe.The red lumen of the line was not drawing back blood.The additional resistance/pulling on the syringe had a mixture of air and blood approximately 1 ml came back into the syringe.The rn stopped attempting to draw from the red lumen and moved on to the blue lumen to draw blood to obtain labs; the blue lumen was able to be flushed and was able to successfully draw blood.The patient became more confused, less responsive and at the end of the blood draw, the patient started complaining of acute onset of shortness of breath so a medical emergency response was activated.A registered respiratory therapist (rrt) was then called for a possible stroke.While waiting for the rapid response team (rrt) to respond to the medical emergency, the rn changed the tego caps on both lumens.While in ct (computed tomography), the patient became increasingly more somnolent requiring a code blue call.A ct angiogram of the head and neck showed air embolism.The patient line was not used in ct for contrast.It was unclear if this was a line malfunction or a user error.No excessive force applied on the device.The central line was initially placed or originally intended for an apheresis procedure and was kept in place to utilize for chemotherapy, infusions, and blood draws from (b)(6) 2023 until the event.The central line was in place for approximately one month and was being accessed/flushed with normal saline daily.The central line was successfully being used for infusions and blood draw daily from (b)(6) 2023 until the event on (b)(6) 2023.The red lumen of the central line had blood return on the previous morning (b)(6) 2023 at the blood draw appointment.Nothing unusual observed on the device prior to use.It was unknown if the line was fl ushed prior to insertion/surgical implantation.The insertion site was treated with chlorohexidine prior to product placement.They were unsure what reverse flow meant.The details of the central line were included from the surgical placement note.The original packaging of the central line was not available.Competitor's iv 3000 central line dressing and competitor's chlorhexidine gluconate (chg) disk were being utilized.The hospital had been in the middle of back order with tego caps and had been using 2 different tego caps (d1005 <(>&<)> d1000) depending on what product was available.The patient had documentation of both types of tego caps used in the 24 hours before the event.Chlorohexidine was used during site care/dressing changes.The company's alcohol prep pad was used to clean the end of the central line between tego cap changes.Competitor's tego cap d1000 and competitor's tego cap d1005 disinfection caps were used at the end of the tego caps when not in use.The reported product was not a single-use device that was reprocessed and reused on the patient.This was also not a laboratory device or laboratory test.The patient was clinically deteriorated bef ore tpa (tissue plasminogen activator)/alteplase was used.The patient received hyperbaric oxygen therapy (emergent hyperbaric treatment) due to the event for treatment of cerebral air embolism.The line could not be removed right away due to emergent hyperbaric t reatment thus it was wrapped in vaseline gauze and covered with tegaderm to make it fully occlusive.The line was removed at bedside the next day was the remedial action.The central line was not replaced.Peripheral iv (intravenous) access was utilized.The line itself had been saved for further investigation but did not have any obvious defects on visual assessment.It was unknown where the occlusion occurred as it did have a significant clot burden or blood clots noted within the central line when it was flushed after it was removed however the line could be flushed with saline.Assessment of the line did not reveal any obvious defects in the central line.There were no break or cracks noted.There was minimal blood loss of less than 50 ml noted during central line removal procedure.Blood transfusion was required to increase patient platelet count above 50,000 to facilitate central line removal.Patient was pancytopenic secondary to chemotherapy.Patient was admitted to the hospital and required icu (intensive care unit) level of care with intubation with ongoing rehabilitation needs for left sided paralysis.Patient was hospitalized from (b)(6) 2023.Patient was transferred to acute rehab on (b)(6) 2023 to recover from left sided paralysis secondary to cerebral air embolism.

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.

Manufacturer Narrative

Change patient status to "alive".Correction: b2(removed other) uf/importer report # 2400100000-2023-8018 h6 patient codes - e2402 (somnolent, less responsive) h6 patient codes ¿ f28 (hyperbaric oxygen therapy) 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.

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.The evaluation found no potentially contributing factors.It was reported that the device was occluded.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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
• 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: 17279873
• MDR Text Key: 318642375
• Report Number: 3009211636-2023-00195
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145040P
• Device Catalogue Number: 8888145040P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention; Hospitalization; Other; Life Threatening