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

Catalog Number	1808550
Medical Device Problem Codes	Difficult to Flush (1251); Fracture (1260); Device Appears to Trigger Rejection (1524); Material Separation (1562); Suction Problem (2170); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: 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.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
On (b)(6) 2022.A patient underwent a port placement procedure using powerport m.R.I.Implantable port.Sometimes later post port placement, it was reported that the catheter was allegedly experienced issues with flushing.It was further reported that the catheter was found to be fractured.Reportedly, the catheter was migrated into patient's heart.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: although the physical device was not returned for evaluation, three images were provided for review.Image 1 shows unremarkable device placed via a right subclavian access.Image 2 shows contrast is being infused; extravasation is noted throughout the arch of the catheter with three areas of focal accumulation.Image 3 shows complete transection of the catheter is noted just proximal to the arch in the neck.The image is suboptimal in this region; the catheter appears to have migrated a few centimeters toward the right heart.Therefore, the investigation is confirmed for the reported catheter fracture, material separation, migration, difficult to flush, suction issues.However, it is inconclusive for the reported device appears to trigger rejection as exact circumstances of the reported event cannot be verified from images.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B3, b5, d6a, d6b, g3, h6 (device, component, method, result) 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
On (b)(6)2022.A patient underwent a port placement procedure using powerport m.R.I.Implantable port.Sometimes later, post port placement, on (b)(6), 2025, it was reported that post port placement, the catheter was allegedly experienced issues with flushing.It was further reported that the catheter was allegedly found fractured.Reportedly, patient allegedly experienced that the catheter migrated to the heart.Reportedly, port previously had a fibrin sheath.The current status of the patient was unknown.

• Brand Name: POWERPORT M.R.I. 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: 23164871
• Report Number: 3006260740-2025-07289
• Device Sequence Number: 18551608
• Product Code: LJT
• UDI-Device Identifier: 00801741027093
• UDI-Public: (01)00801741027093(17)230228(10)REFY2408
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: 02/28/2023
• Device Catalogue Number: 1808550
• Device Lot Number: REFY2408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 05/20/2026
• 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: 35 YR
• Patient Sex: Male
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White