MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 8888422170

Device Problems Migration or Expulsion of Device (1395); Defective Component (2292)

Patient Problems Injury (2348); No Information (3190); Unintended Radiation Exposure (4565)

Event Date 02/17/2020

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 procedure, they said that the peritoneal catheter was found defective (distorted pig¿s tail memory line) and it was mentioned that it did not follow the same path.They placed the device and they are not convinced by the shape of the ¿separated pigtail¿ and they followed up on the patient.Later when performing the catheter test it did not work; they sent a photo where the migrated catheter was observed.Catheter was not repaired and had no leak.There was no reported patient outcome.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the returned photo noted: the image depicts an x-ray, an outline of the catheter can be seen.The hip bones and lower spinal cord are in view.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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 procedure, they said that the peritoneal catheter was found defective, it was stretched or not wel l-formed and it moved out of its original intended position.They placed the device and they are not convinced by the shape, later when performing the catheter test it did not work because they took advantage of the position where the interventionist physician installed it.The catheter was removed and a new one was inserted.The flow of the peritoneal fluid was being test.A titanium connector was placed to join it to the transfer line and leave full peritoneal access, they used saline to wet the catheter and they used iodized soap for asepsis of the abdomen.There was no blood loss, there was no cleaning agent that was used in the device nor luer adapter issue, catheter was not repaired and there was no leak.There was no reported patient injury.

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 procedure, they said that the peritoneal catheter was found defective, it was stretched or not well-formed and it moved out of its original intended position.They placed the device and they are not convinced by the shape, they said that the catheter was seen to move into the right quadrant above iliac crest, out of the installed position, later when performing the catheter test it did not work because they took advantage of the position where the interventionist physician installed it.The catheter did not work, so the patient take laxative, even so it did not work, so it was necessary to remove it and place another one.The flow of the peritoneal fluid was being test.A titanium connector was placed to join it to the transfer line and leave full peritoneal access, it was said that the cuff was remained attached to the skin tissue/ entry point.Radiograph was performed to test the functionality of the catheter after placement, they used saline to wet the catheter and they used iodized soap for asepsis of the abdomen.There was no blood loss, there was no cleaning agent that was used in the device nor luer adapter issue, catheter was not repaired and there was no leak.There was no reported patient injury.

Event Description

According to the reporter, during procedure, they said that the peritoneal catheter was found defective, it was stretched or not well-formed and it moved out of its original intended position.They placed the device and they are not convinced by the shape, they said that the catheter was seen to move into the right quadrant above iliac crest, out of the installed position, later when performing the catheter test it did not work because they took advantage of the position where the interventionist physician installed it.The catheter did not work, so the patient take laxative, even so it did not work, so it was necessary to remove it and place another one.The flow of the peritoneal fluid was being test.A titanium connector was placed to join it to the transfer line and leave full peritoneal access, it was said that the cuff was remained attached to the skin tissue/entry point.Radiograph was performed to test the functionality of the catheter after placement, they used saline to wet the catheter and they used iodized soap for asepsis of the abdomen.There was no blood loss, there was no cleaning agent that was used in the device nor luer adapter issue, catheter was not repaired and there was no leak.

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

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 procedure, they said that the peritoneal catheter was found defective, it was stretched or not well-formed and it moved out of its original intended position.It was stated that 4 other devices was found to have the same issue prior to use and was found on the same event.They placed the device and they are not convinced by the shape, they said that the catheter was seen to move into the right quadrant above iliac crest, out of the installed position, later when performing the catheter test, it did not work because.Since it did not work, patient was told to take laxative, even so it did not work, so it was necessary to remove it and place another one.A titanium connector was placed to join it to the transfer line and leave full peritoneal access, it was said that the cuff remained attached to the skin tissue/ entry point.Eleven days after insertion, radiograph was performed to test the functionality of the catheter after placement, they used saline to wet the catheter and they used iodized soap for asepsis of the abdomen.There was no blood loss, there was no cleaning agent that was used in the device nor luer adapter issue, catheter was not repaired and there was no leak.There was no reported patient outcome.

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 the cannula was found to be kinked, bent, or otherwise deformed.It was reported that there was an ingrowth or catheter migration issue.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Actions have been implemented to mitigate this issue.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: ARGYLE
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9952261
• MDR Text Key: 187417482
• Report Number: 3009211636-2020-00080
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 20884521055657
• UDI-Public: 20884521055657
• Combination Product (y/n): N
• PMA/PMN Number: K180485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2024
• Device Model Number: 8888422170
• Device Catalogue Number: 8888422170
• Device Lot Number: 1903500120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 04/23/2020; 05/06/2020; 05/07/2020; 10/01/2020; 11/11/2020
• Supplement Dates FDA Received: 05/08/2020; 05/21/2020; 09/25/2020; 10/28/2020; 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention