MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 9808560

Device Problems Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

Patient Problem Discomfort (2330)

Event Date 01/04/2022

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that eleven months post port implant via the right subclavian vein, the patient allegedly experienced discomfort and upon x-ray fluoroscopy a few millimeters of the catheter was noted to be fractured.The distal catheter segment and the port body was reportedly removed using radiological procedures.The current status of the patient is unknown.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that eleven months post port implant via the right subclavian vein, the patient allegedly experienced discomfort and upon x-ray fluoroscopy a few millimeters of the catheter was noted to be fractured.The distal catheter segment and the port body was reportedly removed using radiological procedures.The current status of the patient is unknown.

Event Description

It was reported that one year ten months post port implant via the right subclavian vein, the patient allegedly experienced discomfort.It was further reported that the x-ray revealed the device allegedly had a break.Reportedly, the distal catheter segment and the port body was removed using radiological procedures.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport mri isp implantable port attached to a groshong catheter in two segments were returned for evaluation.Gross visual, microscopic evaluation and functional testing were performed.The investigation is confirmed for the reported catheter fracture, material separation and identified deformation and wear issues a complete circumferential break was noted approximately 0.1cm from the distal end of the cath-lock and appeared elliptical in shape.The distal catheter segment was returned and measured approximately 16.8cm in length.A complete circumferential break was noted to the proximal end of the distal catheter segment and appeared elliptical in shape.A circumferential split was noted approximately 0.7 cm from proximal end of the distal catheter segment.The edges of the complete circumferential break on both proximal and distal end appeared to be jagged; the surface of the break appeared to be round in one region and granular in the other region, glossy throughout.During functional evaluation, leak was noted from the circumferential split on the distal catheter segment upon infusion.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.The 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.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 ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13410675
• MDR Text Key: 285924576
• Report Number: 3006260740-2022-00121
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 02/14/2022
• 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