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 Suction Problem (2170); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

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 catheter was allegedly occluded.The facility was able to get blood back flow and flushed with saline, but met resistance.Needle was removed and port was accessed with another needle.Unable to get a good blood draw the port was removed and a new port was placed.There was no reported patient injury.

Manufacturer Narrative

A complete manufacturing review could not be performed, as the lot number is unknown.One powerport mri isp with 8 fr s/l groshong catheter segment, detached from port body, was returned for evaluation.The returned catheter segment was the distal portion of the original catheter, as it had the manufactured distal tungsten plug and three-way valve.The remainder of the catheter and catheter lock were not returned.Both the port body and catheter segment were patent to infusion and aspiration and no leaks were observed where appropriate.Residue was noted throughout the returned sample.Multiple punctures to the port septum were observed.The proximal end of the returned catheter segment exhibited a glossy appearance and striated pattern when viewed under magnification, consistent with trimming of the catheter via a sharp blade, likely done intentionally prior to placement.Although the returned elements were patent to infusion and aspiration, the investigation is inconclusive for the reported inability to aspirate as the catheter was returned detached from the port body and was not returned in its entirety.Per the evaluation results, residue was noted on the returned sample.The identified residue may have contributed to the reported event.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.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 catheter was allegedly occluded.The facility was able to get blood back flow and flushed with saline, but met resistance.Needle was removed and port was accessed with another needle.Unable to get a good blood draw the port was removed and a new port was placed.There was no reported patient injury.

• 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
• MDR Report Key: 7610863
• MDR Text Key: 111440611
• Report Number: 3006260740-2018-01420
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1