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

Model Number 9808560

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Deformation Due to Compressive Stress (2889)

Patient Problem Injury (2348)

Event Date 08/26/2020

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 return of the sample is pending.The investigation of the reported event is currently underway.

Event Description

It was reported that approximately one year two months post port placement, during catheter removal an alleged catheter break was found.It was further reported that x-ray fluoroscopy revealed that the tip of the catheter migrated into atrium.Reportedly the catheter was successfully removed.The patient status was normal.

Event Description

It was reported that approximately one year two months post port placement, during catheter removal an alleged catheter break was found.It was further reported that x-ray fluoroscopy revealed that the tip of the catheter migrated into atrium.Reportedly the catheter was successfully removed.The patient status was normal.

Manufacturer Narrative

H10: 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 with a groshong catheter in two segments was returned for evaluation.Visual, microscopic visual and functional evaluations were performed.The investigation is confirmed for catheter fracture, deformation, catheter tip migration and wear issue as two circumferential kinks were noted approximately 8.3cm and 9.0cm from the distal end of the cath-lock, a complete circumferential break was noted approximately 10.7cm from the distal end of the cath-lock and a circumferential kink was noted approximately 1.9cm from the proximal end of the distal segment.Additionally, the edges of the circumferential split were jagged and both edges of the circumferential break were jagged with a both a smooth rounded and granular surface.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.H10: g4.H6(device: 2988).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): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10566428
• MDR Text Key: 207909864
• Report Number: 3006260740-2020-03319
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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: 10/15/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention