MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	8888231216
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/25/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, on crrt (continuous renal replacement therapy) treatment, patient had a respiratory arrest in which resuscitation (cpr) was required.It was stated that eventually the patient responded to treatment, leading the clinical team to believe that the tamponade was not present at that time.Patient then had another respiratory arrest in which cpr was required along with reintubation and doctor performed a median sternotomy at which time he saw the catheter penetrating the atrium.The doctor pushed the catheter back in and used the perforated opening for his extracorporeal membrane oxygenation (ecmo) cannulation.It was reported that ongoing bleeding occurred and the catheter was still opposing the atrial wall; therefore, the catheter was pulled back and re-secured.It was reported that the device remained in place, but as per the doctor, the patient never recovered from the arrests neurologically.As a result of multiple cardiac arrests (cardiac tamponade) which occurred, the patient met criteria for brain death.It was also reported that the x-ray of catheter placement initially showed positioning in the bottom of the right atrium.It was unclear as to whether the cpr done during the multiple resuscitation efforts may have caused the catheter to penetrate the heart.It was also stated that the catheter was not repaired, there was no leak, tego was not utilized, there was no luer adapter issue.Patient was later declared brain dead and has expired.

• Brand Name: MAHURKAR ELITE
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8272321
• Report Number: 3009211636-2019-00013
• Device Sequence Number: 16664310
• Product Code: NIE
• UDI-Device Identifier: 10884521126947
• UDI-Public: 10884521126947
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K120674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

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 Model Number: 8888231216
• Device Catalogue Number: 8888231216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 01/23/2019
• 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: Death; Other
• Patient Age: 8 YR
• Patient Weight: 27