FDA Adverse Event Malfunction Summary report: N

IOPS GUIDEWIRE ANGLED TIP 2

MDR report key: 17119000 · Received June 13, 2023

Report

Report Number: 3012154226-2023-00001
Event Type: Malfunction
Date Received: June 13, 2023
Date of Event: May 2, 2023
Report Date: June 13, 2023
Manufacturer: CENTERLINE BIOMEDICAL
Product Code: DQX
UDI-DI: 00843152102037
PMA / PMN Number: K190106
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THE LOT WAS RELEASED MEETING ALL ACCEPTANCE CRITERIA. A PICTURE OF THE DAMAGED WIRE TAKEN BY OUR COMPANY REPRESENTATIVE DURING THIS CASE CONFIRMED DELAMINATION OF THE WIRE COATING. AT THIS TIME, WE WERE ABLE TO REPLICATE THIS ISSUE WHEN ONLY USING THE SAME CATHETER (FROM OTHER MANUFACTURER) AS REPORTED IN THIS EVENT.

Description of Event or Problem · 0

DURING A MINIMALLY INVASIVE VASCULAR SURGERY PERFORMED AT VANDERBILT UNIVERSITY MEDICAL CENTER, THE IOPS GUIDEWIRE ATW-2 WAS USED IN CONJUNCTION WITH A 7FR STEERABLE SHEATH AND A 90 CM CATHETER FROM ANOTHER MANUFACTURER. THE GOAL WAS TO CANNULATE THE CELIAC TRUNK OFF THE AORTA. THE GUIDEWIRE WAS IN THE CATHETER, AND THE CATHETER/GUIDEWIRE WERE IN THE STEERABLE SHEATH. THE SHEATH WAS PLACED INTO POSITION AND STEERED TO ENGAGE THE CELIAC OSTIUM SUCH THAT THE GUIDEWIRE CAN BE ADVANCED TO ATTEMPT TO CANNULATE THE VESSEL. THE DOCTOR FELT RESISTANCE TRYING TO PULL THE GUIDEWIRE BACK INTO THE CATHETER/SHEATH. ONCE REMOVED FROM THE PATIENT, THE HYDROPHILIC COATING ON THE TIP OF THE GUIDEWIRE WAS FOUND TO BE DAMAGE UPON INSPECTION. NO PATIENT ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1986774	IOPS GUIDEWIRE ANGLED TIP 2	WIRE	DQX	CENTERLINE BIOMEDICAL	ATW-2	QD02QD23	00843152102037

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR	Male