MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0606150J

Device Problems Fracture (1260); Difficult to Insert (1316); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

Patient Problem Perforation of Vessels (2135)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be 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.H3 other text : device pending return.

Event Description

It was reported that during a port placement procedure via the right subclavian approach, the sheath allegedly broke in the middle when the dilator was pulled out of the sheath.It was further reported that while the dilator was being inserted and withdrawn several times to break the sheath, the vein was allegedly injured by the dilator and perforated the patient's left lung.The current status of the patient is reported to be stable.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the groshong titanium port s/l that are cleared in the us.The pro code and 510 k number for the groshong titanium port s/l are identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 8.0fr peel-apart sheath with vessel dilator were returned for sample evaluation.Visual and function evaluations were performed.The peel-apart sheath was noted to have bunching at the distal end and sheath shaft was noted to be fractured.The distal ends of both the vessel dilator and sheath were noted to be deformed.An attempt to remove the vessel dilator from the peel-apart sheath was performed and retracted with resistance.An attempt to loaded back the vessel dilator to the peel-apart sheath was performed.Resistance was felt and the dilator exited the fractured portion of the sheath shaft.The dilator was pulled out of the sheath is not recommended as per ifu therefore, the investigation is confirmed for the reported fracture, identified material deformation and difficult to insert and difficult to remove and improper procedure or method.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.The definitive root cause could not be determined based upon available information.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.The instruction for use states : precautions: carefully insert the introducer and catheter to avoid inadvertent penetration to vital structures in the thorax.Avoid blood vessel damage by maintaining a catheter or dilator as internal support when using a peel-apart introducer.Avoid sheath damage by simultaneously advancing the sheath and dilator as a single unit using a rotational motion.H10: d4 (expiry date: 09/2025), g3, h6 (device).H11: d1, d4, h6 (method, result, conclusion).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 Description

It was reported that during a port placement procedure via the right subclavian approach, the sheath allegedly broke in the middle when the dilator was pulled out of the sheath.It was further reported that while the dilator was being inserted and withdrawn several times to break the sheath, the vein was allegedly injured by the dilator and perforated the patient's left lung.The current status of the patient is reported to be stable.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Type of Device: 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: 18892881
• MDR Text Key: 337513563
• Report Number: 3006260740-2024-01043
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098253
• UDI-Public: (01)00801741098253
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 0606150J
• Device Lot Number: REHP1309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention