MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1806060
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that six months and twenty-one days post a port placement, the patient allegedly experienced chest pain.It was further reported that the tubing was allegedly fractured and came apart from the port at the site of the port.It was further reported that catheter segment migrated to right atrium.Reportedly, the port was removal in interventional radiology.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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: 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.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one powerport isp mri implantable port, a cath-lock, and a catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.The catheter returned measured approximately 30.4cm in length.A complete circumferential break was noted on the proximal end of the catheter returned.The edges of the complete circumferential break on the proximal end of the catheter returned were noted to be uneven.The surface was noted to be glossy with striations and residue throughout.Upon infusion, resistance was felt and what appeared to be thrombus, was observed exiting with water at the distal end of the catheter.Therefore, the investigation is inconclusive for the reported fracture, material separation and migration issue as further evidence of clinical conditions at the time of use would be necessary to confirm the event.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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: g3.H11: d4 (unique identifier (udi) #), h3, h6 (method, result, 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.
Event or Problem Description
It was reported that six months and twenty-one days post a port placement, the patient allegedly experienced chest pain.It was further reported that the tubing was allegedly fractured and came apart from the port at the site of the port.It was further reported that catheter segment migrated to right atrium.Reportedly, the port was removal in interventional radiology.The current status of the patient is unknown.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
• 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: 20877672
• Report Number: 3006260740-2024-07307
• Device Sequence Number: 12716222
• Product Code: LJT
• UDI-Device Identifier: 00801741026942
• UDI-Public: (01)00801741026942(11)230512(17)250228(10)REHQ1599
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 02/28/2025
• Device Catalogue Number: 1806060
• Device Lot Number: REHQ1599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White