MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPRT MRI ISP 8GR INT; IMPLANTED PORT

Model Number 9808560

Device Problem Break (1069)

Patient Problems Injury (2348); Palpitations (2467)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was not provided, therefore, the device history records could not be reviewed.The device was returned to the manufacturer for evaluation.The investigation is currently under way.

Event Description

It was reported that some time post port device implant, the patient allegedly experienced palpation.It was further reported that x-ray examination demonstrated catheter break where the distal catheter allegedly broke and the segment migrated to the right atrium.Reportedly, the distal catheter segment and the port body were both removed.There was no patient injury reported post removal.

Event Description

It was reported that some time post port device implant, the patient allegedly experienced palpitations.It was further reported that x-ray examination demonstrated catheter break where the distal catheter allegedly broke and the segment migrated to the right atrium.Reportedly, the distal catheter segment and the port body were both removed.There was no patient injury reported post removal.

Manufacturer Narrative

Manufacturing review: a manufacturing review were not provided as batch/lot number were not provided.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.Investigation summary: one powerport isp mri with groshong catheter was received and evaluated.Gross visual observation, microscopic visual observation and functional testing were performed.Observed were multiple punctures and incisions to port septum, both edges of break were jagged and rounded.A complete circumferential break was also noted from the distal end of the cath-lock with both ends of the break in a elliptical shape.This investigation confirms the alleged catheter breakage.The definite root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.

• Brand Name: PPRT MRI ISP 8GR INT
• Type of Device: IMPLANTED PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8745417
• MDR Text Key: 149545582
• Report Number: 3006260740-2019-01818
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

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: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention