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

Catalog Number 1806050J

Device Problems Fracture (1260); Deformation Due to Compressive Stress (2889)

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

Event Date 12/25/2023

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, kit, 6f that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, kit, 6f are identified in d2 and g4.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.Device pending return.

Event Description

It was reported that sometimes post a port placement via left subclavian vein, the catheter was allegedly deformed.It was further reported that the catheter was allegedly found to be torn upon removal.Reportedly, the catheter was removed.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, kit, 6f that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, kit, 6f are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport implantable port attached to a groshong catheter was returned for sample evaluation.Functional, gross visual, tactile and microscopic visual evaluations was performed.Three parallel longitudinal splits were noted on the attached catheter approximately 3.5cm from the cath-lock.Upon infusion, a leak with thrombus from the longitudinal splits was observed on the catheter while water exited the distal end.Aspiration was attempted and was unsuccessful.Therefore the investigation is confirmed for the reported fracture issue.However the investigation is unconfirmed for the reported deformation issue as there was no deformation noted on the catheter.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: h6 (method, result, conclusion).H11: section a through f - the information provided by bd represents all of 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 sometimes post a port placement via left subclavian vein, the catheter was allegedly deformed.It was further reported that the catheter was allegedly found to be torn upon removal.Reportedly, the catheter was removed.There was no reported patient injury.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• 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: 18524855
• MDR Text Key: 333541057
• Report Number: 3006260740-2024-00091
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741163746
• UDI-Public: (01)00801741163746
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063377
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1806050J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• 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