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

Model Number F1031

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

Opsens is still waiting for the return of the device package to complete the investigation report.

Event Description

Before the procedure, it was noticed that the sterile tywek pouch was not sealed at the lower end.

• Brand Name: OPTOWIRE III
• Type of Device: 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
• MDR Text Key: 319511321
• Report Number: 3008061490-2023-00007
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07540184010325
• UDI-Public: (01)07540184010325(11)220212(17)250212(10)OW-2520E
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K191907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1