MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. ULTRA SLIMPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0605640
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Tachycardia (2095); Vascular Dissection (3160)
Date of Event	09/15/2024
Type of Reportable Event	Serious Injury
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.The investigation of the reported event is currently underway.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 during a port placement procedure, the guidewire was allegedly found to be stuck in the introducer needle under x-ray imaging.It was further reported that the guidewire was allegedly difficult to be removed from the needle.Furthermore, the patient's subclavian vein was allegedly torn due to this.Moreover, the patient had allegedly became tachycardic which was managed by anesthesia.The current status of the patient is unknown.
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 j-tip guidewire in a guidewire hoop loaded into an introducer needle was returned for evaluation.Functional, gross visual and dimensional evaluations were performed.The guidewire was noted to have bents.The guidewire was noted to be stuck within the introducer needle.Slight uncoiling was noted on the guidewire portion, distal to the introducer needle hub.The j-tip of the guidewire was noted to be exposed at the distal end of the introducer needle bevel; the exposed portion was noted to be bent.An attempt to further advance the loaded guidewire into the introducer needle was performed and was unsuccessful.The guidewire did not advance through the introducer needle.An attempt to remove the loaded guidewire from the introducer needle was performed and was unsuccessful.The guidewire did not advance through the introducer needle.Therefore, the investigation is confirmed for the reported physical resistance, difficult to remove and identified improper procedure, failure to advance, stretched and deformation issues.However, the investigation is inconclusive for the reported difficult to insert as the exact circumstances at the time of the reported event are unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The root cause for the reported improper procedure is determined to be user error.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f: the information provide 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 during a port placement procedure, the guidewire was allegedly found to be stuck in the introducer needle under x-ray imaging.It was further reported that the guidewire was allegedly difficult to be removed from the needle.Furthermore, the patient's subclavian vein was allegedly torn due to this.Moreover, the patient had allegedly became tachycardic which was managed by anesthesia.The current status of the patient is unknown.

• Brand Name: M.R.I. ULTRA SLIMPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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: 21178947
• Report Number: 3006260740-2024-08525
• Device Sequence Number: 4287461
• Product Code: LJT
• UDI-Device Identifier: 00801741025990
• UDI-Public: (01)00801741025990(17)271031(10)REJN1643
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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: 0605640
• Device Lot Number: REJN1643
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 04/21/2025
• 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 Sex: Unknown