MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 9808560

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Skin Discoloration (2074)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

No medical records or medical images have been made available to the manufacturer.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.The information provided by bard 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 bard.

Event Description

It was reported that the patient had a powerport mri isp implanted via the right subclavian vein.Pigmentation appeared on the patient¿s skin after infusion of anti-cancer agent.X-ray revealed a catheter fracture.The catheter was removed and noted to be fractured 1cm distal from the port stem.The pigment on the patient¿s skin has been fading away gradually.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one powerport isp mri was returned with 8fr groshong catheter.A partial circumferential split was noted 1.1cm distal to the cath-lock.The partial circumferential break is consistent with flexural fatigue; the split was mostly smooth, circumferentially aligned on the catheter, and buckled inward.Therefore, the investigation is confirmed for a flexural fatigue.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that the patient had a powerport mri isp implanted via the right subclavian vein.Pigmentation appeared on the patient¿s skin after infusion of anti-cancer agent.X-ray revealed a catheter fracture.The catheter was removed and noted to be fractured 1cm distal from the port stem.The pigment on the patient¿s skin has been fading away gradually.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one powerport isp mri was returned with 8fr groshong catheter.A partial circumferential split was noted 1.1cm distal to the cath-lock.The partial circumferential break is consistent with flexural fatigue; the split was mostly smooth, circumferentially aligned on the catheter, and buckled inward.Therefore, the investigation is confirmed for a flexural fatigue.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that the patient had a powerport mri isp implanted via the right subclavian vein.Pigmentation appeared on the patient¿s skin after infusion of anti-cancer agent.X-ray revealed a catheter fracture.The catheter was removed and noted to be fractured 1cm distal from the port stem.The pigment on the patient¿s skin has been fading away gradually.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7830995
• MDR Text Key: 118706351
• Report Number: 3006260740-2018-02271
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2019
• 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: 57 YR
• Patient Weight: 70