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); Difficult to Insert (1316); Material Separation (1562); Physical Resistance/Sticking (4012)

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

Event Date 02/20/2024

Event Type  malfunction  

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: 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.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2025) 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 during a port placement procedure, when tried to insert the sheath, there was some alleged resistance felt.It was further reported that the tip of the sheath was allegedly found to be cracked and seperated inside the patient's body.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a port placement procedure, when tried to insert the sheath, there was some alleged resistance felt.It was further reported that the tip of the sheath was allegedly found to be cracked and separated inside the patient's body.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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.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 was returned for evaluation.Visual and functional evaluations were performed on the returned device.The valve cap on the peel-apart sheath t-handle was noted to be fractured.The fractured segment was noted to be loaded within the dilator luer connector.The tip of the sheath was noted to have a complete crack and a part of the sheath was noted to be missing.Therefore the investigation is confirmed for the reported fracture and material separation issues.However the investigation is inconclusive for the reported difficulty in insertion and resistance issues as the exact circumstance at the time of the event reported cannot be reproduced under laboratory conditions.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.(expiration date: 07/2025), g3, h6 (device, method) 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.

• 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: 18957819
• MDR Text Key: 338434136
• Report Number: 3006260740-2024-01212
• 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
• Report Date: 04/12/2024

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: 4808570J
• Device Lot Number: REHS0069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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