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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATHHEMODIALYSISCATH; DIALYSIS CATHETER
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BARD ACCESS SYSTEMS GLIDEPATHHEMODIALYSISCATH; DIALYSIS CATHETER Back to Search Results
Catalog Number 6393230
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a lot history review was completed, which identified that this is the first complaint reported for this lot number.Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged catheter migrated out issue due to the fact that no sample was returned for evaluation.A definitive root cause could not be determined.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.
 
Event Description
It was reported that during maintenance three months post catheter placement, the catheter allegedly migrated out; however, the cuff remained within the subcutaneous tunnel.It was further reported that medication was applied to the patient's skin.The cuff was removed under medical ultrasound (usg).No additional device was placed as infusion treatments were complete.There was no further reported patient injury post removal.
 
Event Description
It was reported that during maintenance three months post catheter placement, the catheter allegedly migrated out; however, the cuff remained within the subcutaneous tunnel.It was further reported that medication was applied to the patient's skin.The cuff was removed under medical ultrasound (usg).No additional device was placed as infusion treatments were complete.There was no further reported patient injury post removal.
 
Manufacturer Narrative
H10: manufacturing review: a lot history review was completed, which identified that this is the first complaint reported for this lot number.Investigation summary: one 23cm gildepath d/l catheter was returned for evaluation.Gross, microscopic visual and functional evaluations were performed.The investigation is inconclusive for catheter migration issue as the exact scenario cannot be replicated.Adhesive residue was noted to the catheter approximately 4.5cm from the distal end of the y-body and there was some spacing between the adhesive and the catheter.Upon infusion of both lumens with water from a 10ml syringe, blood was noted exiting from the distal end.A definitive root cause could not be determined.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: the catalog number identified in section d4 has not been cleared in the us, but is similar to the glidepath hemodialysis catheter products that are cleared in the us.The pro code for the glidepath hemodialysis catheter products is identified in d2.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.
 
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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 Key9982839
MDR Text Key188419093
Report Number3006260740-2020-01447
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741138508
UDI-Public(01)00801741138508
Combination Product (y/n)N
PMA/PMN Number
K051748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6393230
Device Lot NumberREDR0657
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2020
Date Manufacturer Received09/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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