MAUDE Adverse Event Report: GREATBATCH MEDICAL BULK SD VALVE 16FR; INTRODUCER, CATHETER

Model Number 10614-011

Device Problem Material Integrity Problem (2978)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/27/2023

Event Type  Death  

Event Description

A patient was in for a dialysis catheter exchange (temp catheter to a perm catheter).After the first unsuccessful access attempt was unsuccessful, a second attempt was made.While attempting to advance the introducer, fibrotic tissue from previous access caused roll back on the sheath of the device.Final successful attempt using a competitor's kit was made and resulted in blood loss (exact amount unknown).The physician applied pressure to the site and stitched it up, where no further blood loss was experienced.No devices were inside the patient at the time of the cardiac arrest.The procedure was then aborted and a "code" was addressed shortly after.Chest compressions were performed, medications provided, and a blood transfusion was performed, however, the patient expired.Cno in the or stated they believe no device was the cause of patient mortality.This event is related to 2183787-2023-00009.

• Brand Name: BULK SD VALVE 16FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; plymouth MN 55441
• Manufacturer Contact: daniel gil de lamadrid ; 2300 berkshire lane; plymouth, MN 55441
• MDR Report Key: 16449722
• MDR Text Key: 310317412
• Report Number: 2183787-2023-00008
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2023

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: 10614-011
• Device Lot Number: GB7302398
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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
• Patient Age: 77 YR
• Patient Sex: Male