MAUDE Adverse Event Report: OPSENS OPTOWIRE III; CORONARY PRESSURE GUIDEWIRE

Model Number	F1031
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Opsens is still waiting for the return of the device package to complete the investigation report.
Event or Problem Description
Before the procedure, it was noticed that the sterile tywek pouch was not sealed at the lower end.

• Brand Name: OPTOWIRE III
• Common Device Name: CORONARY PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750; blvd du parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer (Section G): OPSENS; 750; blvd du parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: maryem oudhini ; 750; blvd du parc technologoique; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 17356208
• Report Number: 3008061490-2023-00007
• Device Sequence Number: 12028348
• Product Code: DXO
• UDI-Device Identifier: 07540184010325
• UDI-Public: (01)07540184010325(11)220212(17)250212(10)OW-2520E
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2023

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: 12/02/2025
• Device Model Number: F1031
• Device Catalogue Number: F1032
• Device Lot Number: OW-2520E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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 Sex: Unknown