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

Catalog Number	1708061
Medical Device Problem Codes	Fracture (1260); Suction Problem (2170); Obstruction of Flow (2423); Device Tipped Over (2589); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the litigation process that sometime post a port placement, the catheter was allegedly fractured and the patient allegedly developed infection.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records 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.H10: d4 (expiry date: 11/2020) 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.H3 other text : device not returned.
Additional 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: the physical device was not returned for evaluation.Medical record was provided for review.The medical record alleges that the patient underwent right internal jugular vein port placement procedure.The patient¿s right sided port was clogged and was not working.Some days later after port placement, the removal of infected port-a-cath was planned.The port-a-cath was sent for culture the result had proven to have no infection.Five days later, due to difficult vascular access placement of a new bard port was planned via left internal jugular.New port placement on lij was done and using fluoroscopy, the catheter was placed over the guidewire and the length determined to reach the ra/svc junction.The catheter was cut to this length.Attempts to advance the catheter through the sheath were unsuccessful as there was some apparent stenosis.The catheter was withdrawn.The dilator was pulled back under fluoroscopy to be into the left ij.It was noted that during the venogram the takeoff from the left ij to the brachiocephalic was very acute and likely was kinking the softer port provided with the kit.At recommendation a stiffer introducer was selected and this passed easily through this area.Catheter was inserted into this peel-away sheath and advanced without difficulty.After implantation port was aspirated and flushed with heparinized saline easily.Two years and twelve days later the patient presented for exchange of flipped port.Reinsertion of flipped port was performed on the left chest.The wound was then closed.The chest x-ray revealed no evidence of any pneumothorax and confirms that the port was placed correctly with the catheter tip in the svc.Successful fluoroscopically guided placement of port to right chest without complications.The patient had malfunctioning left chest port.The port did not aspirate easily.Contrast was gently injected this demonstrated a kink to the catheter portion of the access device as well as a fibrin sheath formation around the intravascular portion of the catheter.Removal of the port and placement of new port was planned.Catheter was then connected to the port aspirated and flushed well and the port pocket was closed.The port was packed with heparin solution.Therefore, the investigation is confirmed for the reported catheter kink, flipped port and suction issue due to fibrin sheath formation.However, the investigation is inconclusive for the reported fracture issue as no fracture was reported in the medical review record.Furthermore, the clinical condition alleged in the complaint can be confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (device, method).H11: b3, b5, d4 (unique identifier (udi) #), h6 (patient, result).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 or Problem Description
It was reported through litigation process that during a port placement procedure, the softer port had allegedly kink.It was further reported that two years and thirty days post a port removal it was noted that the port did not aspirate properly, kink at catheter portion and allegedly fibrin sheath formation was noted.Furthermore, the port had a fracture and was noted to be flipped.Reportedly, the removal of the port and replacement of a new port was performed.The patient passed away on a later date after placement of a new port.

• Brand Name: POWERPORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• Common Device Name: 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: 19236886
• Report Number: 3006260740-2024-02070
• Device Sequence Number: 8034528
• Product Code: LJT
• UDI-Device Identifier: 00801741026638
• UDI-Public: (01)00801741026638(17)201130(10)REDN3092
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 1708061
• Device Lot Number: REDN3092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female