MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refy2001 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via phone call "the guidewire became stuck in dilator catheter and it became stuck in the tip.The guidewire became stuck in dilator catheter and guidewire tip unraveled.When dilator was pulled out of patient to remove dilator from over the guidewire tip unraveled.Dilator was outside of patient body when wire was stuck and unraveled.".
Additional Manufacturer Narrative
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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a guidewire stuck in the dilator is confirmed.One 70 cm guidewire and one 13 fr dilator were returned for evaluation.The product sticker label indicates lot: refy2001.The distal end of the coil wire was returned elongated and unraveled; however, no breaks in the coil wire or distal weld tip was observed.A complete break in core wire was noted 4 mm from the distal end.Visible deformation and material whitening was noted on the distal end of the dilator.The deformation on the distal orifice on the dilator was flared outwards.Microscopic observation of the distal broken segment of the core wire revealed it to be attached to the distal weld tip.The outer diameter of the guidewire was measured and found to be within manufacturing specification.The deformation present on the dilator and fracture present on the guidewire suggest the guidewire may have been retracted against resistance or kinking of the wire; therefore, the complaint is confirmed.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported via phone call "the guidewire became stuck in dilator catheter and it became stuck in the tip.The guidewire became stuck in dilator catheter and guidewire tip unraveled.When dilator was pulled out of patient to remove dilator from over the guidewire tip unraveled.Dilator was outside of patient body when wire was stuck and unraveled.".

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14028451
• Report Number: 3006260740-2022-01149
• Device Sequence Number: 5938478
• Product Code: NIE
• UDI-Device Identifier: 00801741086960
• UDI-Public: (01)00801741086960
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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: N/A
• Device Catalogue Number: 5605200
• Device Lot Number: REFY2001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown