MAUDE Adverse Event Report: COLOPLAST A/S VORTEK DOUBLE LOOP URETERAL STENT; STENT, URETERAL

Model Number ACB5511002

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, the device was checked for integrity and nothing was visible to the naked eye.The catheter was inserted on (b)(6) 2021.Three pieces of green debris were found in the patient¿s urinary tract, reported to be green debris from the guide (fibers in the order of millimeters or even micrometers).An additional uteroscopy was necessary to remove the debris.The guide was checked for integrity after its ¿release¿; there was no breakage and no evidence to explain the green debris in the urinary tract.The guide was also not folded.

Manufacturer Narrative

Visual inspection of the returned guidewire found tiny holes in the coating, and three soft bends: one approximately 20cm from the distal end, one approximately 60cm from the distal end, and one approximately 110cm from the distal end.Inspection with a microscope revealed severe scratch marks on the wire, worst in the first 20cm from the distal end and in the last 50cm before the proximal end.Along the guide wire are also mnior scratch marks.The scratches go in both directions, indicating that the guide wire had been pulled back and forth over a metal device.The scratched coating material has been pushed, but because the material is flexible, most of it is still attached.The surface of the coating is smooth and uniform where it has not been scratched and there are no signs of flaking.The damage afflicted to the guidewire indicates that the guide wire had been in interaction with a hard device (metal or likewise hard).Lot review found the device met specifications prior to release.

• Brand Name: VORTEK DOUBLE LOOP URETERAL STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11368852
• MDR Text Key: 233341641
• Report Number: 9610711-2021-00015
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K013921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

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 Expiration Date: 09/05/2021
• Device Model Number: ACB5511002
• Device Catalogue Number: ACB551
• Device Lot Number: 7324365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention