MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATHHEMODIALYSISCATHETER; DIALYSIS CATHETER

Catalog Number 6393230

Device Problems Defective Component (2292); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: a sample evaluation could not be performed as the samples were not returned.However, two (2) electronic photos were reviewed.The first photo shows the catheter partially in the patient and the cuff can be seen having came out of the patient.The second photo shows a slightly different view of the catheter with the cuff having come out of the patient, the lumens in this photo seem clearer than in the first picture where the lumens seemed more opaque.From the photo it is clear the catheter has dislodged and that the cuff is no longer connected to the tissue in the patient.The investigation is confirmed for catheter dislodgement.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.(expiration date: 12/2020).

Event Description

It was reported that some time post dialysis catheter placement, the catheter allegedly became dislodged with exposure of the cuff.There was no reported patient injury.

Event Description

It was reported that some time post dialysis catheter placement, the cuff allegedly failed to adhere to the tissue which resulted in catheter dislodgement.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: a sample evaluation could not be performed as the samples were not returned.However, two (2) electronic photos were reviewed.The first photo shows the catheter partially in the patient and the cuff can be seen having came out of the patient.The second photo shows a slightly different view of the catheter with the cuff having come out of the patient, the lumens in this photo seem clearer than in the first picture where the lumens seemed more opaque.From the photo it is clear the catheter has dislodged and that the cuff is no longer connected to the tissue in the patient.The investigation is confirmed for a damaged/defective cuff.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Expiration date: 12/2020.

• Brand Name: GLIDEPATHHEMODIALYSISCATHETER
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8932048
• MDR Text Key: 155574500
• Report Number: 3006260740-2019-02508
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741138508
• UDI-Public: (01)00801741138508
• Combination Product (y/n): N
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6393230
• Device Lot Number: REDP3359
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 35