MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI ISP, 8 FR GROSHONG; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1808560

Device Problem Fracture (1260)

Patient Problems Embolism (1829); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review 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.(expiration date: 11/2021).

Event Description

It was reported that sometime post port placement, the catheter allegedly broken and migrated to the pulmonary artery.The patient's status is unknown.

Manufacturer Narrative

Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged broken catheter issue due to the fact that no sample was returned for evaluation.Although a definitive root cause could not be determined, the following contributing factors inadequate connection strength during routine use, mushrooming tubing at port stem base resulting in compression damage, flexural fatigue during routine use could have potentially caused or contributed to the reported event.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: d4 (expiration date: 11/2021),g4 h11: b5,d2,h6(patient) h10: 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 that some time post port implant, the catheter allegedly broke and migrated to the pulmonary artery.Reportedly, the heath care provider tried to remove the distal catheter segment via snare, however, could not remove it and left in the patient.The patient's status is unknown.

• Brand Name: POWERPORT MRI ISP, 8 FR GROSHONG
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10005716
• MDR Text Key: 190143068
• Report Number: 3006260740-2020-01461
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027116
• UDI-Public: (01)00801741027116
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

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 Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: RECU2402
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 04/30/2020
• Supplement Dates FDA Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 76