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

Model Number 8888145039P

Device Problems Material Frayed (1262); Difficult to Remove (1528)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during insertion of a palindrome catheter, the guide wire remained inside the patients atrium and it was not able to be removed with the usual procedures.Patient was then transferred to another hospital for intervention and evaluation by a heart surgeon.The guide (wire) was withdrawn without incident.The patient was sent to the icu (intensive care unit) and subsequently returned to base hospital.The catheter was not repaired, there was no leak, and there was no luer adapter issue.The event led to patient extended hospitalization.The patient was stable.

Event Description

According to the reporter, during insertion of a palindrome catheter, the guide wire broke in the distal area (untailed the cable that wrapping it) when the guide and peelable introducer sleeve were being removed, it remained inside the patients atrium and it was not able to be removed with the usual procedures.Radiography (imaging study) was requested which was evaluated by a vascular surgeon at the medical institution.The patient was then transferred to another hospital for intervention, for evaluation by a heart surgeon and due to the need for a critical bed.It was reported that the guide (wire) was withdrawn without incident.The patient was sent and admitted to the icu (intensive care unit) for one night and subsequently returned to base hospital.It was mentioned when the guidewire was removed, the device was not intact but all pieces were accounted for by performing rotational movement on its same axis.It was also stated that prior to breaking there was no abnormal conditions noted and it was uneventful.There was no resistance in inserting the guide wire.There were no tools used to remove the guidewire, no excessive force was used in removing the guide wire and there were no other defects/damages found on the product.The guidewire provided with the kit was being used.The insertion site was treated with skin preparation according to internal hospital protocol prior to product placement.There was nothing unusual observed on the device prior to use and no other products were utilized with the device.The catheter was not installed, it was not repaired, no tego utilized, no occlusion, no leak, and there was no luer adapter issue.It was also stated that there was minimal blood loss.The event led to patient extended hospitalization.A new procedure was performed after three days to insert a new catheter.The new catheter was installed in another anatomical site and the procedure was completed.The patient was stable.

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 Description

According to the reporter, during insertion of a palindrome catheter, the guide wire broke in the distal area (untailed the cable that wrapping it) and there was difficulty encountered while removing the guide with peelable introducer sleeve, it remained inside the patients atrium and it was not able to be removed with the usual procedures.Radiography (imaging study) was requested which was evaluated by a vascular surgeon at the medical institution.The patient was then transferred to another hospital for intervention, for evaluation by a heart surgeon and due to the need for a critical bed.It was reported that the guide (wire) was withdrawn without incident.The patient was sent and admitted to the icu (intensive care unit) for one night and subsequently returned to base hospital.It was necessary to remove guide wire and catheter from the patient simultaneously (in one action) due to the alleged defect.It was mentioned when the guidewire was removed, the device was not intact but all pieces were accounted for by performing rotational movement on its same axis.It was also stated that prior to breaking there was no abnormal conditions noted and it was uneventful.There was no resistance in inserting the guide wire.There were no tools used to remove the guidewire, no excessive force was used in removing the guide wire and there were no other defects / damages found on the product.The guidewire provided with the kit was beingused.The insertion site was treated with skin preparation according to internal hospital protocol prior to product placement.There was nothing unusual observed on the device prior to use and no other products were utilized with the device.The catheter was not installed, it was not repaired, no tego utilized, no occlusion, no leak, and there was no luer adapter issue.It was also stated that there was minimal blood loss and blood transfusion was not required.The scan was done because of the problem caused with the guide.The patient was hospitalized for catheter change but with the incident, the hospitalization was prolonged.A new procedure was performed after three days to insert a new catheter.The new catheter was installed in another anatomical site and the procedure was completed.The patient was stable.

Manufacturer Narrative

Additional information: b5, g4, h3, h6 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 the first image depicts an x-ray where the catheter can be seen along with the skeleton.The second image depicts the product information label.It was reported that the guide wire was unable to be withdrawn and was frayed, coiled or unraveled.The reported issues could not be 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 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.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10537738
• MDR Text Key: 207122580
• Report Number: 3009211636-2020-00221
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521158023
• UDI-Public: 10884521158023
• Combination Product (y/n): N
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145039P
• Device Catalogue Number: 8888145039P
• Device Lot Number: 1923400231
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization