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

Model Number	8888412619
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, there was recurrence of hypogastric pain each time there were an administration of intraperitoneal physiological serum via the catheter, with an abdomen that remained perfectly flexible, without fever.There was no malposition of the catheter.The patient left the hospital and since then there was no recurrence of pain.Four (4) days later, a new test after premedication of water injection and recurrence of immediate pain occurred.Significant pain experienced by the patient and needed for re-hospitalization.Suspension of oncology management of peritoneal carcinosis with cancellation of the immunotherapy injection and leading to the end of the study.It was also stated that they had to perform the catheter ablation surgery.
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, there was recurrence of hypogastric pain each time there were an administration of intraperitoneal physiological serum via the catheter, with an abdomen that remained perfectly flexible, without fever.There was no malposition of the catheter.The patient left the hospital and since then there was no recurrence of pain.Four (4) days later, a new test after premedication of water injection and recurrence of immediate pain occurred.Significant pain experienced by the patient and needed for re-hospitalization.The hospitalization for treatment was initially planned for 1 to 2 days and was extended up to 3 days (total of 3 days duration) for a new injection attempt.There was nothing unusual observed on the device prior to use.Sodium chloride (nacl) was used for flushing prior to use as provided in the protocol and nivolumab has never been injected and the pain appeared during the nacl rinse.There were no other products being utilized with the device.On the second day of hospitalization new attempt to inject nacl was done and had recurrence of pain and the rinsing was stopped.The infusion was stopped when the pain appeared and the pain was resolved simultaneously as soon as the infusion was stopped.7 days after hospitalization, new injection attempt was made and after paracetamol and spasfron premedication was given before the infusion attempt but had no effect, recurrence of pain occurred and the rinsing was stopped.Suspension of oncology management of peritoneal carcinosis with cancellation of the immunotherapy injection and leading to the end of the study.It was also stated that they had to perform the catheter ablation surgery as the medical intervention done to the patient and this was part of a clinical trial.The catheter was removed from the patient's body and no new device was implanted based on the decision shared between the surgeon and the patient.The patient was fine and there were no after-effects of the event.
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.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10362263
• Report Number: 3009211636-2020-00175
• Device Sequence Number: 2648071
• Product Code: FJS
• UDI-Device Identifier: 10884521004450
• UDI-Public: 10884521004450
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: 8888412619
• Device Catalogue Number: 8888412619
• Device Lot Number: 1718100124
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/12/2020; 09/24/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 08/28/2020; 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 56