MAUDE Adverse Event Report: CENTERLINE BIOMEDICAL IOPS GUIDEWIRE ANGLED TIP 2

Model Number	ATW-2
Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: IOPS GUIDEWIRE ANGLED TIP 2
• Common Device Name: WIRE
• Manufacturer (Section D): CENTERLINE BIOMEDICAL; 10000 cedar avenue; cleveland OH 44106
• Manufacturer (Section G): YOKOWO CO.,LTD.; 1112 kanohara, tomioka-shi; gunma, 370-2 495; JA 370-2495
• Manufacturer Contact: amanda shade ; 10000 cedar avenue; cleveland, OH 44106 ; 2162067364
• MDR Report Key: 17119000
• Report Number: 3012154226-2023-00001
• Device Sequence Number: 20621452
• Product Code: DQX
• UDI-Device Identifier: 00843152102037
• UDI-Public: (01)00843152102037(11)220318(17)240318(10)QD02QD23
• Combination Product (Y/N): N
• PMA/510(K) Number: K190106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: ATW-2
• Device Catalogue Number: ATW-2
• Device Lot Number: QD02QD23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White