MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER PORT ISP M.R.I., 8FR GROSHONG; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 4808570J

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problems Pain (1994); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

The catalog number has not been cleared in the us but is similar to the power port isp m.R.I., 8fr groshong that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.Expiry date: 11/2021.

Event Description

It was reported that one year eleven months and nine days post port placement procedure in right internal jugular vein, the circumferential cracks was allegedly found near tip of the removed catheter.It was further reported that the patient experienced pain and swelling around the port body.Reportedly, antiemetics was administered for experienced symptoms.The current status of the patient is stable.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs confirmed the reported complaint, however, performance testing could not reproduce the reported complaint.Based on all available evidence and complaint investigations of a similar nature, the investigation determined the reported complaint was due to an intermittent connection with the battery.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the power port isp m.R.I., 8fr groshong that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong 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 powerport mri implantable port attached to a groshong catheter was returned for evaluation and one image was provided for review.Gross visual, microscopic visual, tactile and functional evaluations were performed on the returned device.The investigation is confirmed for the reported fracture issue as partial circumferential break and split were noted on the attached catheter and edges of both partial compound breaks on the attached catheter were noted to be uneven.Upon infusion, leaks were observed from the breaks on the attached catheter.The investigation is also confirmed for the identified material twist issue as the material was noted to be twisted in the provided image.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.H10: (expiry date: 11/2021).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 one year eleven months and nine days post port placement procedure via right internal jugular vein, the circumferential cracks was allegedly found near tip of the removed catheter.It was further reported that when antiemetics were administered, pain and swelling were observed around the port body.The device was removed from the patient.There was no reported patient injury.

• Brand Name: POWER PORT ISP M.R.I., 8FR GROSHONG
• 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: 16459594
• MDR Text Key: 310420466
• Report Number: 3006260740-2023-00582
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741175725
• UDI-Public: (01)00801741175725
• 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,Followup
• Report Date: 05/08/2023

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: 4808570J
• Device Lot Number: REEQ2923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/29/2023; 05/08/2023
• Supplement Dates FDA Received: 04/25/2023; 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2020
• 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
• Treatment: ANTIEMETICS
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female