MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATHHEMODIALYSISCATH; 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 08/17/2019

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation and a photo has been provided for review.The investigation of the reported event is currently underway.(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.

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.Investigation summary: one glidepath d/l 15f catheter and one electronic photo were returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.A photo review was also performed.The investigation is inconclusive for failed tissue in-growth and catheter dislodgement, as the actual conditions at the time of the reported event are unknown and could not be reproduced.The returned photo did not appear to show the conditions at the time of the reported event.Discoloration on the catheter was observed distal to the bifurcation and blood residue was observed throughout the device.The cuff was observed to be adhered in place on the catheter and not move during functional testing.The cuff appeared to be matted with no observable tears and no regions lacking fibers were observed.The definitive root cause could not be determined based upon available information.The actual conditions at the time of the reported event could not be reproduced in the lab.The discoloration of the catheter and the observed blood residue is consistent with characteristics of a catheter that has been in contact with the body.The observed matting on the cuff may have contributed to the reported failed tissue in-growth/catheter dislodgement issue by not facilitating adequate tissue in-growth; however, it cannot be determined if the matting was present prior to implantation or occurred as a result of being in contact with tissues.Other potential contributors to the reported event are cuff/skin attachment surface area not sufficient, poor material choice, improper placement and excessive force applied.It is unknown if procedural and/or manufacturing issues contributed to the reported 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.(expiration date: 12/2020).

Event Description

It was reported that sometime post dialysis catheter placement, the tissue allegedly failed to grow around the cuff which resulted dialysis catheter dislodgement.There was no reported patient injury.

• Brand Name: GLIDEPATHHEMODIALYSISCATH
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9008927
• MDR Text Key: 157819179
• Report Number: 3006260740-2019-02646
• 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: 11/08/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Manufacturer Received: 08/17/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 70