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

Catalog Number	CP00002
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/09/2025
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 is currently being performed.The return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.Section a through f: the information provide 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 or Problem Description
On (b)(6) 2024, a patient underwent a port placement procedure using the ti power port isp.On (b)(6) 2025, it was noted that the catheter allegedly fractured at the connection site and embolized centrally.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: one vaccess ct low profile implantable port, one catheter in two segments and one cath-lock were returned for evaluation.Visual, microscopic, tactile, functional and dimensional evaluations were performed on the returned device.Along with returned sample, five x-ray images were provided for review.A catheter was returned and measured approximately 0.6cm in length.The complete circumferential break was noted on the proximal end of the catheter.A complete compound break was noted on the distal end of the catheter.The distal catheter segment was returned and measured approximately 23.5cm in length.A complete compound break was noted on the proximal end of the distal catheter segment returned.The edges of the complete compound break on the distal end of the catheter were noted to be jagged.The surface was noted to be granular with residue throughout.The edges of the complete compound break on the proximal end of the distal catheter segment were noted to be jagged.The surface was noted to be granular with residue throughout.The x-ray images review show a port in the right chest with the catheter disconnected from the port immediately at the connection site, the catheter has moved centrally.Therefore, the investigation is confirmed for the reported fracture, material separation and migration issues.The definitive root cause for the reported issues could not be determined based upon available information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (component, method, result, conclusion) section a through f: the information provide 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 or Problem Description
On (b)(6) 2024, a patient underwent a port placement procedure using the ti power port isp.On (b)(6) 2025, it was noted that the catheter allegedly fractured at the connection site and embolized centrally.The current status of the patient was unknown.

• Brand Name: POWERPORT ISP IMPLANTABLE PORT, GROSHONG, 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: 22434621
• Report Number: 3006260740-2025-04585
• Device Sequence Number: 3152503
• Product Code: LJT
• UDI-Device Identifier: 00801741111488
• UDI-Public: (01)00801741111488(17)250930(10)REJQ2491
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/19/2025

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: 09/30/2025
• Device Catalogue Number: CP00002
• Device Lot Number: REJQ2491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White