MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8806061

Device Problems Fracture (1260); Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Physical Resistance/Sticking (4012)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

It was reported that during the preparation of a port placement procedure, the guide wire allegedly could not pass through the introducer needle with multiple attempts.The procedure was completed by using another device.There was no patient contact.

Manufacturer Narrative

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 kit was received for evaluation and one video was provided for review.Visual, microscopic, dimensional and functional evaluations were performed.Stretching was noted throughout the guidewire.The inner core-wire was noted to be fractured and detached from the guidewire proximal to the hub.The guidewire felt stuck within the introducer needle upon functional testing.The video shows the difficulty in advancing the guidewire through the introducer needle and also the guidewire was noted to be retracted in and out of the introducer needle.Therefore, the investigation is confirmed for the reported failure to advance and the identified physical resistance, improper method, stretched, fracture, material separation issues.Although, the definitive root cause could not be determined based upon available information, use error could have been contributed to the identified improper procedure issue.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product labeling inadequacy.The instructions for use was reviewed and it states: precautions: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and guidewire as a unit to help prevent the needle from damaging or shearing the guidewire.H10: d4 (expiration date: 11/2023).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 : see h10.

• Brand Name: POWERPORT ISP MRI 6F CHRONW/OS
• 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: 17903224
• MDR Text Key: 325851829
• Report Number: 3006260740-2023-04587
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098963
• UDI-Public: (01)00801741098963
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/05/2023

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: 8806061
• Device Lot Number: REFZ3204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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