MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET EXCHANGE KIT; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5397270
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that the arterial lumen collapsed during dialysis.The device was removed and replaced in ir (interventional radiology).There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one 27 cm glidepath dialysis catheter was returned for evaluation.Visual inspection noted crimping marks on both the veinous and arterial lumens.Therefore, the investigation is confirmed for the alleged catheter kink.Extension leg kinking is most likely a result of repeated use of clamps.However, the definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that the arterial lumen collapsed during dialysis.The device was removed and replaced in ir (interventional radiology).There was no reported patient injury.

• Brand Name: GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET EXCHANGE KIT
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8001838
• Report Number: 3006260740-2018-03013
• Device Sequence Number: 1311173
• Product Code: MSD
• UDI-Device Identifier: 00801741012310
• UDI-Public: (01)00801741012310
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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
• Operator of Device: Health Professional
• Device Model Number: 5397270
• Device Catalogue Number: 5397270
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 01/27/2019
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 89