MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLINE CV CATHETER, POLYURETHANE DUAL-LUMEN, 6F; CHRONIC CATHETERS

Catalog Number	0700615
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a chronic catheter placement procedure in the intrajugular vein, the guidewire was allegedly found to be frayed.It was further reported the separated guidewire fragment allegedly got stuck inside the patient.Reportedly, the guidewire fragment was attempted for removal through interventional radiology but it was unable to be retrieved.Therefore, the retained fragment had to be repositioned into a small chest wall vein.The frayed guidewire is still inside the patient.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 06/2025) h11: section a through f ¿ the information provided by bd represents all 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.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one straight tip guidewire was received for evaluation.Visual, microscopic and dimensional evaluation were performed.Three electronic photos were provided for review.The distal portion of the guidewire was noted to be frayed which is the core wires, were observed protruding from the distal tip of the guidewire.The guidewire was noted to be uncoiled at the distal portion.The portion was also noted to be stretched.The round core wire was noted to be protruding from one uncoiled area of the guidewire.Therefore, the investigation is confirmed for the reported fracture, material separation, and identified stretched, unraveled issues.However, the investigation is inconclusive for the reported entrapment and difficult to remove issues as the functional testing was unable to be performed due to the condition of the sample and as the exact circumstance at the time of the event reported was unknown.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all 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.
Event or Problem Description
It was reported that during a chronic catheter placement procedure in the left intrajugular vein, the guidewire was allegedly found to be frayed.It was further reported the separated guidewire fragment allegedly got stuck inside the patient.Reportedly, the guidewire fragment was attempted for removal through interventional radiology but it was unable to be retrieved; therefore, the retained fragment had to be repositioned into a small chest wall vein and the frayed guidewire was still left inside the patient's body.The current status of the patient is unknown.

• Brand Name: POWERLINE CV CATHETER, POLYURETHANE DUAL-LUMEN, 6F
• Common Device Name: CHRONIC CATHETERS
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19456827
• Report Number: 3006260740-2024-02759
• Device Sequence Number: 20812637
• Product Code: LJS
• UDI-Device Identifier: 00801741036606
• UDI-Public: (01)00801741036606
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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 Catalogue Number: 0700615
• Device Lot Number: REHW1145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/21/2024
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 109 KG