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

Model Number PERITONEAL CATHETER

Device Problem Infusion or Flow Problem (2964)

Patient Problems Unintended Radiation Exposure (4565); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

Title: peritoneal dialysis catheter dysfunction due to fibrin clots following treatment with tranexamic acid: a clinical case source: bulletin de la dialyse it domicile 2021 pp121-128.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature case study, tranexamic acid (exacyl®) was used in a peritoneal dialysis patient for gastrointestinal bleeding of unknown origin.The use of tranexamic acid led to the tenckhoff catheter dysfunction because of fibrin clots in the dialysate.The emergence of fibrin clots a few days after the start of tranexamic acid treatment, which never occurred again after the end of the treatment, and the anti-fibrinolytic function of tranexamic acid favors this treatment¿s role in fibrin clot occurrence.The patient, has been receiving peritoneal dialysis (pd) since october 2018 for chronic tubulointerstitial nephritis.It was stated that the patient used to dialyze 6 days a week, 8 hours per night, with 4 exchanges of 2000 ml of glucose dialysate (physioneal® 40 1.36%, baxter) and 2000 ml of icodextrin (extraneal®, baxter) during the day with a tenckhoff swan-neck catheter.Her latest results were a kt/v of 1.7, a creatinine clearance equal to 50 l/wk/1.73m², and a highly permeable peritoneum on her last peritoneal equilibration test.On 15-jan2021, the patient reported drainage problems overnight with cycler and had to stop dialysis in the middle of the night.The patient was admitted to the pd (peritoneal dialysis) unit, where the patient received an unprepared abdominal x-ray that showed the tenckhoff catheter was in place.A 2000 ml continuous ambulatory pd exchange (capd) performed by pd nurses proceeded without issues, with rapid drainage, rapid infusion, and clear liquid.The patient returned home, and the following dialyses went well.On 26-jan2021, the patient re-contacted the pd center for the same drainage problems with a cycler that repeatedly alarmed ¿check patient line¿.The patient was admitted to the pd unit again, this time bringing her overnight drainage bag.Several pieces of fibrin were evident in the night pd bag although the patient had never had fibrin in the bags (pictures in the article attached).The involvement of ta (tranexamic acid) treatment was suspected in the formation of fibrin in the dialysate.This treatment was stopped, but no other treatment was started, particularly no heparin in the dialysate bags.Two days later, the patient returned with the same problem.The catheter was completely blocked, and it was impossible to drain or infuse dialysate despite repeated rinses of the catheter with the syringe with physiological saline.The patient benefited from a lock of the urokinase + taurolidine catheter with the following protocol: taurolock® u (theradial) 50000 iu diluted in 5 ml of the solvent supplied with the product, and 4.5 ml (volume of the tenckhoff swan-neck catheter+ extension line) was injected slowly into the patient's catheter.Once this operation was complete, a betadine plug was put back on the catheter and was allowed to act between three and four hours, and then the dialysate was drained.This lock failed to regain catheter patency.The heparin catheter (concentration of 2500 iu/ml) was locked according to the same protocol as above, allowing for the excellent functionality of the catheter to be restored.The dialysate bags were then heparinized with 2500 iu of heparin in each 2 l bag for 24 hours.The patient has resumed apd according to her previous protocol; no new episode of dysfunction or any fragment of fibrin has appeared after a three-month follow-up.Her hemoglobin level was stable and nonnal, and her last fibrinogen from march 23 was 6.5 g/l.Ta has been permanently stopped.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation, based upon all information received.The device was not returned, but a photo was available for evaluation.The photo's showed fibrin fragments in the peritoneal dialysis bag.It was reported, that the device was occluded.The reported issue 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.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: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12419134
• MDR Text Key: 269745620
• Report Number: 3009211636-2021-00234
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

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 Model Number: PERITONEAL CATHETER
• Device Catalogue Number: PERITONEAL CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 11/24/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female