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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI L/P PORT W/BROV 6.6F; IMPLANTABLE PORT
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BARD ACCESS SYSTEMS MRI L/P PORT W/BROV 6.6F; IMPLANTABLE PORT Back to Search Results
Model Number 0603880
Device Problems Defective Component (2292); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Patient Problem Vascular Dissection (3160)
Event Date 09/25/2019
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 05/2023).
 
Event Description
It was reported that during port device implant procedure, the dilator was allegedly damaged while dilating over the guidewire.Therefore, the dilator could not be used to complete the procedure.Reportedly, dissection through the skin and subcutaneous tissue was performed.The patient was reported as stable.
 
Event Description
It was reported that during port device implant procedure, the dilator was allegedly damaged while dilating over the guidewire.Therefore, the dilator could not be used to complete the procedure.Reportedly, dissection through the skin and subcutaneous tissue was performed.The patient was reported as stable.
 
Manufacturer Narrative
H10: manufacturing review: as the lot number for the device was provided, a manufacturing review will be performed.Investigation summary: a sample evaluation could not be performed as the samples were not returned.However, 3 photographs were returned for evaluation the investigation is confirmed for introducer damage as one of the photos shows apparent deformation on the tips of the sheath and the dilator.The definite root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: d4 (expiration date: 05/2023); g4 h11: h6 (resultsand conclusion) 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.
 
Manufacturer Narrative
H10: manufacturing review: as the lot number for the device was provided, a manufacturing review will be performed.Investigation summary: one sheath/dilator was returned for evaluation.Gross examination showed the element to have been effectively used in that the vessel dilator showed multiple multi aspect curves and the distal end evidence of distortion damage with splits.Detailed examination of the peel apart sheath showed a rumpled crease mark just distal to the peel apart handles, just proximal to the distal end, and a length peeled back segment at the distal end of the sheath.The tip of the introducer sheath, when split, was found to manifest some evidence of the tipping manufacturing process, which tapers the sheath tip.In addition, 3 photographs were returned for evaluation the photo evaluation confirms introducer damage as one of the photos shows apparent deformation on the tips of the sheath and the dilator.The definite root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: d4 (expiration date: 05/2023); g4 h11: b5, h2, h3, h6 (device code, method and results).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 port implant, the dilator allegedly damaged while dilating over the guidewire.Therefore, the dilator could not be used to complete the procedure.Reportedly, dissection through the skin and subcutaneous tissue was performed.The patient was reported as stable.
 
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Brand Name
MRI L/P PORT W/BROV 6.6F
Type of Device
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9226836
MDR Text Key163835872
Report Number3006260740-2019-03307
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741025846
UDI-Public(01)00801741025846
Combination Product (y/n)N
PMA/PMN Number
K924250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Model Number0603880
Device Catalogue Number0603880
Device Lot NumberRECW1866
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2020
Date Manufacturer Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age11 YR
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