MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, KIT, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1809600

Device Problems Difficult to Flush (1251); Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Suction Problem (2170); Migration (4003)

Patient Problems Chest Pain (1776); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2015

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 through litigation process that post a port placement, the port allegedly failed to deliver medication and the port catheter allegedly broke into several pieces.It was further reported that the fragmented port catheter was removed on second attempt.However, the current status of the patient is unknown.

Manufacturer Narrative

H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.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 five months and twenty-eight days post port placement, the port had stopped functioning and so the removal of port-a-cath was performed.Reportedly, the port and catheter were removed intact.Around ten days later, two views of the chest x-ray showed a 7 cm radiopaque tubular structure projecting over the right lower lobe.Impression was given as, radiopaque foreign body identified in the right lower lobe consistent with the known history of the fractured catheter tip.Critical result showed the retained foreign object was recognized by physician after one day and communicated to healthcare provider.On the same day, the patient allegedly experienced chest pain.Computed tomography angiogram of chest revealed that the port-a-cath was removed one year ago.However, the patient had a known retained catheter tip in the chest which has been previously evaluated at outside hospital.Angiogram findings also showed that there was a hyperdense catheter shaped foreign body within the pulmonary arterial vasculature, with proximal tip in the right main pulmonary artery and the distal tip within a subsegmental pulmonary arterial branch in the superior segment of the right lower lobe.The main pulmonary artery measures 3.1 cm in diameter.Other parameters were normal.Limited evaluation of the upper abdominal organs shows a prior cholecystectomy and gastric bypass.The patient underwent right heart catheterization with removal of the foreign body.The broken catheter tip has not been removed after an attempted but unsuccessful percutaneous removal procedure.Around a day later, foreign body removal in pulmonary artery was performed.Through the right internal jugular access, a braun multi snare was used initially to try to snare the dislodged catheter.Despite multiple attempts, removal was unsuccessful.The proximal end of the catheter did not move despite making contact, suggestive of fibrosis.The snare was unable to reach the distal end of the catheter for removal.A bmw wire was then used to try to wrap around the mid portion of the catheter, which was unsuccessful as well.The braun snare was switched out with a smaller but stiffer angiotech atrieve snare.Again, with multiple attempts, the catheter was unable to be retrieved.Unsuccessful catheter removal in the pulmonary artery.Therefore, the investigation is confirmed for the reported fracture, material separation, migration, suction issue and difficult to flush and difficult to remove.Furthermore, 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.H10: d4 (expiration date: 06/2016), g2, g3, h6 (device, method) h11: b3, b5, d6 (medical device explant date), e1, h1, h6 (patient, result) 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 not returned.

Event Description

It was reported through the litigation process that five months and twenty-eight days post a port placement via the left subclavian vein, the port was allegedly difficult to flush and the port had stopped functioning.It was further reported that the catheter allegedly fractured.Furthermore, the patient allegedly experienced chest pain, and it was identified that the fractured catheter had allegedly migrated into the patient¿s right pulmonary artery under computed tomographic examination.In addition, the patient allegedly developed with thrombosis.However, the retained portion of the broken catheter tip was successfully removed on third attempt.Reportedly, the port and catheter were removed intact.The current status of the patient is unknown.

• Brand Name: POWERPORT M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, KIT, 9.6F
• 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: 18873185
• MDR Text Key: 337700745
• Report Number: 3006260740-2024-01013
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027130
• UDI-Public: (01)00801741027130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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: 1809600
• Device Lot Number: REYG2063
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/16/2024
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 180 KG