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

Catalog Number	5613150
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device has not been returned to the manufacturer for evaluation.Device not returned for evaluation.
Event or Problem Description
It was reported by the customer that during insertion of power trialysis short-term curved extension dialysis catheter, the catheter got hung up on the guidewire during the normal exchange.Initially, provider thought there was a problem with the catheter, left the guidewire in place and requested a second catheter.The second catheter also hung up on the guidewire in the same way as the first catheter.Upon further inspection, the guidewire is frayed at the distal end.No immediate harm to patient detected.No other information was provided.Additional information received 05/18/2023: the event occurred during a non-emergent trialysis catheter insertion for renal replacement therapy.Event discovered the inserting provider noted the frayed guidewire while attempting to remove the guidewire after threading the catheter into place.The wire remained in 1 piece, no fragments noted.No complications noted.No patient harm.
Event or Problem Description
It was reported by the customer that during insertion of power trialysis short-term curved extension dialysis catheter, the catheter got hung up on the guidewire during the normal exchange.Initially, provider thought there was a problem with the catheter, left the guidewire in place and requested a second catheter.The second catheter also hung up on the guidewire in the same way as the first catheter.Upon further inspection, the guidewire is frayed at the distal end.No immediate harm to patient detected.No other information was provided.Additional information received 05/18/2023: the event occurred during a non-emergent trialysis catheter insertion for renal replacement therapy.Event discovered the inserting provider noted the frayed guidewire while attempting to remove the guidewire after threading the catheter into place.The wire remained in 1 piece, no fragments noted.No complications noted.No patient harm.
Additional Manufacturer Narrative
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.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed; however, the exact cause is unknown.One 0.035 in.J-tip guidewire was returned for evaluation.An initial visual observation showed use residue on the returned sample.A section of the guidewire near its proximal end was observed to be damaged.The core wire of the guidewire was found to be intact and unbroken.A microscopic observation revealed the coiled wire of the guidewire in the damaged section was kinked in multiple locations.The damage observed on the returned guidewire appears to have been caused by extreme compression forces and/or excessive manipulation of the guidewire during the insertion process.However, since the catheters reportedly involved in the event were not also returned for evaluation, the root cause of this damage could not be determined.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17011609
• Report Number: 3006260740-2023-02148
• Device Sequence Number: 15362828
• Product Code: NIE
• UDI-Device Identifier: 00801741041945
• UDI-Public: (01)00801741041945
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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 Catalogue Number: 5613150
• Device Lot Number: REHN0906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: Black Or African American