MAUDE Adverse Event Report: VOLCANO CORPORATION OMNIWIRE PRESSURE GUIDE WIRE, J-TIP; WIRE, GUIDE, CATHETER

Model Number	J-TIP 89185J
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Inner lumen of the omniwire pressure guide wire that contains the fractional flow reserve transducer disengaged from the outer wire lumen.This disengagement caused a threading effect that caused acute flow disruption that resulted in further intervention to correct.

• Brand Name: OMNIWIRE PRESSURE GUIDE WIRE, J-TIP
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive; san diego CA 92130
• MDR Report Key: 15939802
• Report Number: 15939802
• Device Sequence Number: 6210638
• Product Code: DQX
• UDI-Device Identifier: 00845225003050
• UDI-Public: (01)00845225003050
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2022
• Report Date (Section F): 11/08/2022

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 Model Number: J-TIP 89185J
• Device Catalogue Number: 89185J
• Device Lot Number: 0302437107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 11/08/2022