MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT TI L/P 6 CHRONOFLEX INT W/SUTURE PLUGS ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8716000

Device Problems Difficult to Remove (1528); Stretched (1601); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2024) 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.H3 other text : device not returned.

Event Description

It was reported that during a port placement procedure in the right subclavian chest via the right internal jugular vein, while entering the guidewire along the puncture needle, there was an alleged trace of resistance felt after entering eight centimeters of depth.It was further reported that the guidewire was allegedly difficult to be retracted.Furthermore, the tip of the guidewire was allegedly found to be stringed when removed from the patient's body.The procedure was completed by using another device.There was no reported patient injury.

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: the sample was not returned for evaluation.Two electronic photos were provided for review.Both the photos show the bent guidewire and the distal part of the wire was noted to be stretched.Therefore, the investigation is confirmed for the reported deformation and identified stretched issues.However, the investigation is inconclusive for the reported physical resistance issue as no objective evidence was provided for review.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: 05/2024), g3, h6 (method) h11: h6 (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.H3 other text : device not returned.

Event Description

It was reported that during a port placement procedure in the right subclavian chest via the right internal jugular vein, while entering the guidewire along the puncture needle, there was an alleged trace of resistance felt after entering eight centimeters of depth.It was further reported that the guidewire was allegedly difficult to be retracted.Furthermore, the tip of the guidewire was allegedly found to be stringed when removed from the patient's body.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: POWERPORT TI L/P 6 CHRONOFLEX INT W/SUTURE PLUGS ATTACHABLE 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: 19030256
• MDR Text Key: 339208632
• Report Number: 3006260740-2024-01424
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098932
• UDI-Public: (01)00801741098932
• 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,Followup
• Report Date: 04/23/2024

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: 8716000
• Device Lot Number: REGT5315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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