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

Catalog Number 4808560

Device Problems Fracture (1260); Material Separation (1562); Migration (4003)

Patient Problems Pain (1994); Tachycardia (2095); Perforation of Vessels (2135); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/29/2023

Event Type  Injury  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the reported fracture, material separation and migration as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.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.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 Description

It was reported through litigation process that sometime post a port placement, the port had allegedly fractured, perforated and migrated.It was further reported that patient allegedly developed thrombosis and diagnosed with ventricular tachycardia.However, the current status of the patient is unknown.

Event Description

It was reported through litigation process that sometime post port placement procedure, the port had fractured, migrated and perforated into multiple arteries.It was further reported that patient experienced chest pain and developed thrombosis.Reportedly, the patient was diagnosed with ventricular tachycardia.However, the current status of the patient is unknown.

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: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one year and eight months post port placement, the patient experienced continual chest pain until port removal.Around one day later, a retained fragment was discovered in right atrium with unsuccessful removal.Around seven days later, the patient consulted for evaluation for retained catheter removal.Ultrasound guidance was used, which demonstrated a patent right common femoral vein.The wire and inner-catheter dilator were removed.Postprocedural chest x-ray demonstrates no retained catheter fragments.The patient tolerated the procedure well with no immediate complications.All wires and catheters were removed.Therefore, the investigation is confirmed for the reported fracture, material separation and migration.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.Based upon the available information, the definitive root cause is unknown.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 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.

• Brand Name: POWERPORT ISP 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: 18562298
• MDR Text Key: 333456059
• Report Number: 3006260740-2024-00146
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027345
• UDI-Public: (01)00801741027345
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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: 4808560
• Device Lot Number: REDX1710
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 37 YR
• Patient Sex: Female