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

Model Number	ATW-2
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
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.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.
Event or Problem Description
During a minimally invasive vascular surgery performed at vanderbilt university medical center, dr.Advanced the iops guidewire atw-2 through a catheter and sheath (both from another manufacturer) that had already cannulated the pmeg fenestration to access the sma.The iops wire was switched out for another wire from another manufacturer.Before inserting it back into the sheath to access the celiac artery, dr.Noticed that the wire covering over the sensor was becoming detached and decided not to proceed any further.No patient adverse effects were reported due to this occurrence.

• 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: 17119007
• Report Number: 3012154226-2023-00002
• Device Sequence Number: 7154384
• 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: 05/09/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White