MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER; 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	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported guide wire cannot be pulled out after catheter placement.It was stated the conservative measures and action taken were the entire device is removed and another catheter is inserted.(b)(6) 2022 - the returned guidewire exhibited multiple kinks.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of unable to remove a guidewire from a catheter was confirmed but the exact cause remains unknown.One guidewire and 15 cm powertrialysis catheter were returned for evaluation.The guidewire was found to contain bent and kinked regions at the 4.5cm, 24.5, and 32 cm locations.The proximal section of the guidewire was found to be elongated due to the core wire being frayed.Microscopic inspection of the distal and proximal weld tips revealed them to be intact.A non-complainant guidewire was inserted through the catheter and no obstructions or resistance was noted.An attempt to pass the returned guidewire revealed resistance at the kinked regions.The outer diameter of the guidewire was measured near the deformed and damaged regions and was found to be within manufacturing specification.The presence of kinks in the guidewire likely contributed to the resistance experienced and fraying of the guidewire during attempted removal; therefore, the complaint is confirmed.Based on the information provided, possible contributing factors that may cause kinks in the guidewire include advancement against resistance and deformation during handling and use.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16018270
• Report Number: 3006260740-2022-05786
• Device Sequence Number: 6678962
• Product Code: NIE
• UDI-Device Identifier: 00801741041983
• UDI-Public: (01)00801741041983
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

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: 5618150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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