MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1678300

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/20/2024

Event Type  Injury  

Event Description

It was reported that sometime post a port placement, the j tip on the wire allegedly got caught in the heart muscle.It was further reported that the device retracted with a piece of muscle due to wire caught in the heart and it was freed with much resistance.The current status of the patient is reported to be stable.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 06/2025).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 : device pending return.

Manufacturer Narrative

H10: 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 j-tip guidewire was received for evaluation.Visual and functional testing were performed.No visual anomalies were noted.No bends or uncoiling were observed throughout the guidewire.Therefore, the investigation is inconclusive for the reported entrapment and difficult to remove issue, as the exact circumstance 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.H10: d4 (expiration date: 06/2025), g3.H11: h6 (method, result, conclusion).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.

Event Description

It was reported that sometime post a port placement, the j tip on the wire allegedly got caught in the heart muscle.It was further reported that the device retracted with a piece of muscle due to wire caught in the heart and it was freed with much resistance.The current status of the patient is reported to be stable.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX, 8F
• 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: 19102870
• MDR Text Key: 340103676
• Report Number: 3006260740-2024-01743
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741110801
• UDI-Public: (01)00801741110801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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: 1678300
• Device Lot Number: REHV0295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/14/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/27/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male