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 Difficult to Insert (1316); Peeled/Delaminated (1454); Deformation Due to Compressive Stress (2889)

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

Event Date 12/23/2021

Event Type  malfunction  

Event Description

It was reported that during a port placement procedure via the internal jugular vein, the guidewire allegedly found to be peeled.It was further reported that the device had resistance issue on insertion.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.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 mri isp implantable port, one flushing connector and one cath-lock attached to a groshong catheter, one introducer needle, one straight non-coring needle, one right-angle non-coring needle, one vein pick, one cath-lock, one syringe, one j-tip guidewire in a guidewire hoops, one 8.0fr introducer peel-apart sheath and vessel dilator, one safety infusion set, one tunneler and one guidewire loaded in a guidewire hoop were returned for evaluation.Gross, microscopic visual and functional testing were performed.The investigation is confirmed for the identified guidewire deformation issue as the guidewire appeared to be bend on the distal tip.However, the investigation is inconclusive for the reported difficulty in insertion issue as the exact circumstances at the time of reported event was unknown and the clinical conditions cannot be replicated to confirm these failures.Furthermore, the investigation is unconfirmed for reported peeled issue as no peeling was noted on the received physical sample.A definitive root cause could not be determined based upon the 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.(expiration date: 08/2023).

• 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: 14797130
• MDR Text Key: 296717272
• Report Number: 3006260740-2022-02421
• 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
• Report Date: 06/15/2022

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: REFU1451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/24/2022
• 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