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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A batch history review (bhr) of refv2317 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer, that during catheter insertion, they were not able to remove guidewire as it broke in a few pieces.They were worried that the piece of the wire is within the patient.No other information was provided.
Event or Problem Description
It was reported by the customer, that during catheter insertion, they were not able to remove guidewire as it broke in a few pieces.They were worried that the piece of the wire is within the patient.No other information was provided.
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: sample analysis, patient severity, applicable previous investigation(s), complaint and lot history review, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken guidewire is confirmed.One 0.035 in.J-tip guidewire was returned for evaluation.An initial visual observation showed use residue on the returned sample.The coiled wire was observed to be unraveled near the proximal end of the guidewire, and both core wires of the guidewire were observed to be broken and protruding from the coiled wire.A microscopic observation revealed both weld tips of the guidewire were present, and no breaks were found in the coiled wire.The break sites in the core wires of the guidewire were both observed to be tapered with mostly flat, smooth, and granular fracture surfaces, which is indicative of tensile failure caused by excessive pulling forces on the guidewire.As a note, the product instructions for use (ifu) states: ¿do not pull back guidewire over needle bevel as this may sever the end of the guidewire.The introducer needle must be removed first.Also, if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resistance before proceeding.Withdraw needle and guidewire if cause of resistance cannot be determined.¿.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT
• Common Device Name: CATHETER, HEMODIALYSIS, 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: 16359681
• Report Number: 3006260740-2023-00414
• Device Sequence Number: 12459780
• Product Code: NIE
• UDI-Device Identifier: 00801741041983
• UDI-Public: (01)00801741041983
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Followup
• Report Date (Section B): 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 5618150
• Device Lot Number: REFV2317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 02/11/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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: Required Intervention
• Patient Sex: Unknown