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 11/02/2019

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.The investigation of the reported event is currently underway.(expiration date: 04/2021).

Event Description

It was reported that sometime post dialysis catheter placement, the catheter was allegedly dislodged due to failed tissue in-growth on cuff.Reportedly, the device was removed.There was no reported patient injury.

Manufacturer Narrative

H10: 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 14.5 fr d/l glidepath 23 cm str hemodialysis catheter with surecuff was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is inconclusive for catheter dislodgement and failed tissue in-growth on cuff.The cuff did not slide along the catheter under manual manipulation.The cuff appeared to be slightly variably patchy/thin in density content.There appeared to be an uneven distribution of blood/tissue residue throughout the cuff, with approximately one-half of the cuff having a substantial amount of blood/tissue residue and the half appearing to be sparse in blood/tissue residue.There appears to be a distinct, sharp boundary between the region with substantial blood/tissue residue and the region that appears to be sparse in blood/tissue residue.The fibers appeared to be matted throughout the cuff.Sutures were present in both holes of the suture wings.The definite root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the 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.H10: d4 (expiration date: 04/2021); g4.H11: b5, h3, h6 (results and conclusion).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that sometime post dialysis catheter placement, the catheter allegedly dislodged due to failed tissue in-growth on cuff.Reportedly, the device was removed.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: 9417550
• MDR Text Key: 169283334
• Report Number: 3006260740-2019-03767
• 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: 03/05/2020

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: REDS4918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 68