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

Catalog Number	0602850
Medical Device Problem Codes	Fracture (1260); Material Too Rigid or Stiff (1544); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988); Migration (4003)
Health Effect - Clinical Code	Fever (1858)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.H10: (expiration date: 11/2011).H11: section a through f ¿ the information provided 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
It was reported that fifteen years, one month and twenty days post a port placement, the port was planned for removal due to recurrent febrile episodes and non-functional implantable chamber.It was further reported that the catheter ruptured during removal and allegedly migrated into the right ventricle.Furthermore, the part of the catheter recovered allegedly appeared fragile with a friable aspect of the silicone and two sections of silicone in the two centimeter upstream of the ruptured zone.Reportedly, the catheter piece was retrieved via femoral route and the port was removed.The current status of the patient is reported to be stable.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one titanium dome implantable port and a groshong catheter were received for evaluation.Along with sample, five photos were provided for review.Functional, gross visual, tactile and microscopic visual evaluations were performed.Complete circumferential breaks were noted on both ends of the catheter segment that were elliptical in shape.The edges of the complete circumferential break on the proximal end were noted to be uneven and the surface was noted to be granular.The surface was noted to be round and smooth in one region and granular in the other region.Splits were noted on the border of the regions.The edges of the complete circumferential break on the distal end of the catheter were noted to be jagged.The surface was noted to be round and smooth in one region and granular in the other.A split was noted on the border of the regions.Therefore, the investigation is confirmed for the reported catheter fracture, material separation and identified wear and deformation issues.However, the investigation is inconclusive for the reported migration and material too stiff issues as exact circumstances at the time of the event was unknown.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) h11: d4 (unique identifier (udi) #), h6 (method, result, conclusion) h11: section a through f ¿ the information provided 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
It was reported that fifteen years, one month and twenty days post a port placement, the port was planned for removal due to recurrent febrile episodes and non-functional implantable chamber.It was further reported that the catheter ruptured during removal and allegedly migrated into the right ventricle.Furthermore, the part of the catheter recovered allegedly appeared fragile with a friable aspect of the silicone and two sections of silicone in the two centimeters upstream of the ruptured zone.Reportedly, the catheter piece was retrieved via femoral route and the port was removed.The current status of the patient is reported to be stable.

• Brand Name: TITANIUM DOME IMPLANTABLE PORT, GROSHONG 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: 20472583
• Report Number: 3006260740-2024-05967
• Device Sequence Number: 12665610
• Product Code: LJT
• UDI-Device Identifier: 00801741025754
• UDI-Public: (01)00801741025754(11)090116(17)111130(10)RESL0483
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K880571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 11/30/2011
• Device Catalogue Number: 0602850
• Device Lot Number: RESL0483
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2009
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White