MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI ISP, 8 FR GROSH, INTER W/O SUT. PLUG, S/L; IMPLANTABLE PORT

Model Number	1808561
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 06/2022).
Event or Problem Description
It was reported that some time post port device implant, the port allegedly broke and migrated to the right ventricle.It was further reported the port body was removed and the catheter segment was removed at another facility.The patient status is unknown.
Event or Problem Description
It was reported that some time post port device implant, the port allegedly broke and migrated to the right ventricle.It was further reported the port body was removed and the catheter segment was removed at another facility.The patient status is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number for the device was provided; therefore, a device history record was performed.A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this 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.Investigation summary: one powerport mri isp with groshong catheter was received and evaluated.Gross examination, microscopic examination and functional testing were performed.The port segment showed multiple puncture access and multiple incisions of the port septum.A complete circumferential break was noted approximately 12.5cm from the distal end of the cath-lock.The investigation confirms the alleged broken port with embolism issue.The definitive root cause could not be determined.H10: d4 (expiration date: 06/2022), g4, h4 h11: g1, h3, h6 (results, conclusion) 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 MRI ISP, 8 FR GROSH, INTER W/O SUT. PLUG, S/L
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8899305
• Report Number: 3006260740-2019-02414
• Device Sequence Number: 13517950
• Product Code: LJT
• UDI-Device Identifier: 00801741027123
• UDI-Public: (01)00801741027123
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1808561
• Device Catalogue Number: 1808561
• Device Lot Number: REDP4503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 108