MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATHHEMODIALYSISCATH; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number 6393190

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

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.Investigation summary: one 14.5 fr d/l glidepath 19 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 failed tissue ingrowth to cuff and catheter dislodgement, as the exact circumstances at the time of the reported event are not fully known.The blood residue distribution throughout the cuff was observed to be uneven, with some regions appearing to be sparse in blood residue.The cuff fibers appeared to be matted throughout the cuff.The cuff did not move under manual manipulation.Sutures were observed to be in both suture holes.The definitive root cause could not be determined based upon available information, as the exact clinical circumstances at the time of the reported event are unknown.Potential contributors to the reported event are no tissue in-growth, cuff/skin attachment surface area not sufficient, cuff profile does not encourage in-growth (e.G.Weave too tight), poor material choice, inadequate dimensional design (e.G.Cuff too close to bifurcation), improper placement and excessive force applied.It is unknown if the observed matting of the cuff fibers was present prior to catheter insertion or occurred during catheter indwelling time or occurred during catheter removal.It is unknown if procedural, patient and/or catheter maintenance issues contributed to the reported event.Labeling review: the cause of the event in question is unknown, and so the applicability of any particular portion of the instructions for use (ifu) or other labeling is unknown.However, 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 ifu instructs on positioning the cuff in the patient, and therefore the product labeling will be considered adequate.(expiry date: 08/2020).

Event Description

It was reported that sometime post dialysis catheter placement, tissue allegedly failed to grow around the cuff and the catheter dislodged.Reportedly, a new device was placed.There was no reported patient injury.

• Brand Name: GLIDEPATHHEMODIALYSISCATH
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9516398
• MDR Text Key: 175104761
• Report Number: 3006260740-2019-04004
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741138492
• UDI-Public: (01)00801741138492
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6393190
• Device Lot Number: RECX1196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• 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 Age: 43 YR
• Patient Weight: 62