MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (ALPHACURVE) (24CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5835190
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebu0835 showed no other similar product complaint(s) from this lot number.Device not returned yet.
Event or Problem Description
It was reported that the wire was broken near the curved end of the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: this is the only complaint that has been reported for this corporate lot number to date.All necessary inspections were performed throughout all the manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot, in regards the problem described.Investigation summary: the complaint of a damaged guidewire was confirmed but the exact cause was unknown.The product returned for evaluation was a 0.038¿ x 70cm guidewire (within hoop).Gross visual evaluation of the wire found white/clear crystalline residue, similar to saline residue, and red residue consistent with blood.A kink between two wire coils was seen 0.7cm from the transition to the ¿j¿ tip.No breakage of either the core or the coil wire was seen.Microscopic examination of the guidewire found no potential evidence supporting a root cause to the guidewire kink.While no specific physical evidence was seen which supported a root cause to the kink, it was likely that the wire was not inserted into the needle in its current condition as the damage was obvious.No potential damage/defect related to manufacture of the device was seen.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 or Problem Description
It was reported that the wire was broken near the curved end of the catheter.There was no reported patient injury.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (ALPHACURVE) (24CM)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7335697
• Report Number: 3006260740-2018-00422
• Device Sequence Number: 979633
• Product Code: MSD
• UDI-Device Identifier: 00801741013492
• UDI-Public: (01)00801741013492
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/24/2018

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: 5835190
• Device Catalogue Number: 5835190
• Device Lot Number: REBU0835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1