MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT TI L/P 6 CF INT WOSP ATT SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8716001

Device Problems Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

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 powerport slim implantable port kit with the following components were received: one powerport slim implantable port, one syringe, one tunneler, one vein pick, one cath-lock, one 6.5fr peel-apart sheath and vessel dilator, one flush connector and cath-lock loaded to one catheter, one introducer needle loaded to a guidewire in a guidewire hoop and 2 unknown components.Functional, gross visual, tactile, microscopic and dimensional evaluations were performed.Uncoiling was noted on the guidewire loaded to the introducer needle and the guidewire appeared to be stuck within the introducer needle.The core wires were noted to have complete breaks within the guidewire.An attempt to remove the loaded guidewire from the introducer needle was performed and was successful after resistance was felt.In addition to the returned physical sample, two electronic photos and one video was provided for review.The photo shows the uncoiled guidewire and the video shows an attempt to insert or remove the wire in the needle was failed, as the guidewire was noted to be stuck within the introducer needle.Therefore, the investigation is confirmed for the reported failure to advance, difficult to remove, physical resistance and identified fracture, stretched and material separation issues.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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.H10: d4 (expiration date: 01/2025) 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.

Event Description

It was reported that during a port placement procedure, the port was allegedly difficult to deliver the guide wire after insertion and unable to remove the guide wire.It was further reported that guide wire allegedly stuck with the puncture needle and could not be withdrawn easily.There was no reported patient injury.

• Brand Name: POWERPORT TI L/P 6 CF INT WOSP ATT SL
• 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: 18541618
• MDR Text Key: 333200036
• Report Number: 3006260740-2024-00117
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098949
• UDI-Public: (01)00801741098949
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072549
• 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
• Report Date: 01/17/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 8716001
• Device Lot Number: REHP2887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2024
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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