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

Catalog Number 0602830

Device Problems Difficult to Flush (1251); Fracture (1260); Material Separation (1562); Suction Problem (2170); Material Twisted/Bent (2981); Migration (4003)

Patient Problems Infiltration into Tissue (1931); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/03/2024

Event Type  Injury  

Event Description

It was reported that six months and eight days post a port placement procedure, the port allegedly had suction issue and difficult to inject to the chamber.It was further reported that the catheter was allegedly found to be fractured.Reportedly, catheter was migrated into the left hepatic vein to the very top of the superior vena cava, and loops into the right heart endo cavity, within the right atrium and ventricle.Reportedly, the patient allegedly experienced extensive alveolar-interstitial infiltration of the right upper lobe and apical segment of the right lower lobe.The current status of the patient was unknown.

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.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2026).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.H3 other text : device pending return.

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: one bardport mri implantable port and a groshong catheter were returned for evaluation.Two images were provided for review.Visual, microscopic, functional and tactile evaluation was performed on the returned device.A complete circumferential break was noted on the proximal end of the catheter returned.The edges of the complete circumferential break was noted to be jagged and the surface was noted to be granular.The port body was patent to both infusion and aspiration.The image shows the catheter curled in the heart and also shows the port in the right thigh with a needle inserted with no catheter attached.Therefore the investigation is confirmed for the reported fracture, material separation, migration and material twist issues.However the investigation is inconclusive for the reported suction issue and flush issues as there were no difficulty in aspiration and infusion was identified during evaluation and the sample evaluation results indicating no difficulty under laboratory conditions are not by themselves sufficient to confirm that this event did not occur under clinical conditions.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.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 Description

It was reported that six months and eight days post a port placement, the port allegedly had suction issue and was difficult to inject into the chamber.It was further reported that the catheter was allegedly found to be fractured.Furthermore, the catheter was allegedly migrated fro the left hepatic vein to the very top of the superior vena cava, and loops into the right heart endo cavity, within the right atrium and ventricle.Reportedly, the patient allegedly experienced extensive alveolar-interstitial infiltration of the right upper lobe and apical segment of the right lower lobe.The current status of the patient was unknown.

• Brand Name: M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Type of Device: 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: 18605722
• MDR Text Key: 334092202
• Report Number: 3006260740-2024-00244
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025716
• UDI-Public: (01)00801741025716
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K873213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 0602830
• Device Lot Number: REFZ1402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 80 KG