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

Model Number DIALYSIS UNKNOWN

Device Problem Material Frayed (1262)

Patient Problems Bradycardia (1751); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Insufficient Information (4580)

Event Date 06/16/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the literature, patient #3, was scheduled for permcath insertion by the right jugular vein due to malfunction of the avf on the left arm.During the surgery, the wire of the palindrometm insertion kit was placed over the central venous catheter (cvc) into the right atrium and the cvc was removed leaving the wire in place.Further on the implantation, the two dilatators of increasing size were used without any problems.To prepare for the placement of the introducer with the pull apart sheath, the skin incision was widened.The introducer and sheath were also placed over the wire.After advancing approximately five centimeters a strong resistance was felt and the patient expressed pain.The placement was immediately stopped.In fluoroscopic imaging the wire was folded unexpectedly.The patient became bradycardic and somnolent.Massive transfusion, resuscitation and a sternotomy were performed as heart lung machine (hlm) was established.The vein lesion was repaired by the surgeon and bleeding stopped.The patient was weaned from hlm and transferred to the intensive care unit (icu), where after an initial stable phase of a few hours a rapid circulatory failure occurred that was believed to be related to a new bleeding episode and then the patient died.It was stated that prior to insertion there was nothing unusual observe on the catheter and flushing was done.The insertion site was treated in accordance to the institutional disinfection standards prior to product placement.The catheter was not replaced/repaired.There were no other products being utilized with the device.

• Brand Name: DIALYSIS UNKNOWN
• 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: 12506678
• MDR Text Key: 272482655
• Report Number: 3009211636-2021-00264
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2021
• 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): Death; Required Intervention