MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH 19CM ST EX KIT; LONG-TERM HEMODIALYSIS CATHETER

Model Number	5397190
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.Expiry date (03/2020).
Event or Problem Description
It was reported that the tunneler tip allegedly broke within the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturer 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 tunneler in two segments was returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for damaged/defective tunneler, as the proximal end of the tunneler plastic tip was detached.The ends of the breaks were jagged and scoring marks were noted on the proximal fragment.The exact root cause for the damaged tunneler could not be determined.However, it is likely that supplier issues may have contributed to reported event.The scoring marks on the proximal tunneler fragment are consistent with characteristics of manipulating the tunneler with tools (e.G.Hemostats).Handling the tunneler with tools may have also contributed to the reported event.Expiry date (03/2020).
Event or Problem Description
It was reported that during the placement of the dialysis catheter, the tunneler allegedly broke in the catheter.Reportedly, the broken piece of the tunneler was removed, however, same catheter was used to complete the procedure.There was no reported patient injury.

• Brand Name: GLIDEPATH 19CM ST EX KIT
• Common Device Name: LONG-TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8698166
• Report Number: 3006260740-2019-01657
• Device Sequence Number: 2663598
• Product Code: MSD
• UDI-Device Identifier: 00801741012297
• UDI-Public: (01)00801741012297
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: 5397190
• Device Catalogue Number: 5397190
• Device Lot Number: REDN0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 170