MAUDE Adverse Event Report: CENTERLINE BIOMEDICAL, INC. INTRA-OPERATIVE POSITIONING SYSTEM (IOPS); GUIDEWIRE

Model Number	ATW-2
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record shows that the lot was released meeting all acceptance criteria.The hydrophilic coating on the distal end of the guidewire was visually confirmed to be partially peeled but was still attached to the guidewire.The tracking data from the procedure was used to create a video playback simulation of the guidewire and catheter positions inside the patient's anatomy when the issue occurred.Based on this simulation, it is likely that the damage was caused by the patient's tortuous anatomy which forced the guidewire into a sharp angle (>90°) and the user rapidly retracting the guidewire when resistance was felt.The guidewire instructions for use (ifu) have been updated to include a warning related to device manipulation and instructions on how to proceed if any resistance is felt but the guidewire lot used during this event did not contain this updated ifu.
Event or Problem Description
During a bevar (branched endovascular aortic repair) procedure, an iops atw-2 guidewire was damaged upon removal from the patient.During removal, the physician noted some resistance but continued to retract the guidewire.After the guidewire was removed, it was found that the hydrophilic coating on the distal tip had begun to delaminate.No patient adverse effects were reported due to this occurrence.

• Brand Name: INTRA-OPERATIVE POSITIONING SYSTEM (IOPS)
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): CENTERLINE BIOMEDICAL, INC.; 4535 renaissance pkwy; cleveland OH 44128 5701
• Manufacturer (Section G): YOKOWO CO.,LTD.; 1112 kanohara, tomioka-shi; gunma 370-2495 ; JA
• Manufacturer Contact: amanda shade ; 4535 renaissance pkwy; cleveland, OH 44128-5701 ; 2162067364
• MDR Report Key: 21306703
• Report Number: 3012154226-2025-00001
• Device Sequence Number: 8848166
• Product Code: DQX
• UDI-Device Identifier: 00843152102037
• UDI-Public: (01)00843152102037(11)240403(17)260403(10)2404-2005
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2025

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: 04/03/2026
• Device Model Number: ATW-2
• Device Catalogue Number: ATW-2
• Device Lot Number: 2404-2005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White