MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; IMPLANTED PORTS

Model Number 9808560

Device Problems Fracture (1260); Suction Problem (2170); Deformation Due to Compressive Stress (2889)

Patient Problems Pain (1994); Swelling (2091)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review, a device history record review, and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one powerport mri isp attached to a groshong catheter were returned for evaluation.Visual, microscopic and functional evaluation were performed on the returned device.Two circumferential kinks were noted on the catheter approximately 7.6cm and 8.4cm from the distal end of the cath-lock.A partial circumferential break was noted approximately 9.0cm from the distal end of the cath-lock.The edges of the partial circumferential break were jagged with smoothed and rounded surface.The observed characteristics are consistent with damage due to flexural fatigue.The breaking with smoothed and rounded edges are characteristic of flexural fatigue, which is due to the repetitive kinking of the catheter.Further during functional evaluation both the port body and catheter segment were patent to infusion with a leak noted at the site of break.Aspiration was attempted, but was unsuccessful.Therefore, the investigation is confirmed for aspiration problem, fracture, deformation and leak.A definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(device: 1250) 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 approximately one year post port placement through right internal jugular vein, the port was allegedly unable to aspirate.Reportedly the patient experienced neck pain and swelling and a x-ray image allegedly demonstrated leakage of anticancer agent.It was further reported that the port system was removed and the catheter was removed percutaneously.The current patient status was unknown.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Type of Device: IMPLANTED PORTS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10926439
• MDR Text Key: 218901864
• Report Number: 3006260740-2020-03595
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2020

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: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 66 YR