MAUDE Adverse Event Report: OPSENS SAVVYWIRE; PRE-SHAPED PRESSURE GUIDEWIRE

Model Number	F3001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	01/05/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation of the wire is not possible as the hospital discarded it by the end of the procedure.According to the device history record, the lot number osw-00030 has been released following specifications, no dr nor nc were documented.Although as stated by the physician the source of the pericardial effusion or at what point it happened is unknown, he does not feel that the savvy wire has a relation to the unfortunate outcome.The risks associated with the unfortunate event are well documented and are disclosed in the savvywire instructions for use (ifu): adverse events that may result from the use of this device include, but are not limited to: access site or vessels complications, additional surgical procedure, allergic reactions, amputation, aneurysm, angina, arrhythmia, bleeding, cardiac or vessel perforation/dissection, coronary obstruction, death, embolism, fibrillation, foreign body/wire fracture, heart block, hematoma, hypotension/hypertension, infection, kidney injury/failure, myocardial infarction, need for permanent pacemaker, pericardial effusion, pneumothorax, stroke or other neurologic event, spasm, tamponade, thrombus, valve dysfunction or complications, vasospasm, vessel occlusion, wire entrapment/entanglement, x-ray radiation exposure complications.The ifu also mentions the following precaution such as: never advance, pull or torque a savvywire against resistance without first determining the reason for the resistance under fluoroscopy.Excessive force against resistance may result in damage to the wire and/or to the anatomy.Fluoroscopic guidance should be used during manipulations of the savvywire.Care should be taken when the tip of the savvywire is positioned, moved or torqued in the ventricle.
Event or Problem Description
Savvywire was properly placed into lv with pigtail catheter.After valve was deployed echo tee showed an infusion.Echo physician unsure of location of infusion or what caused the infusion.Patient was tapped to address infusion.Subsequently, the team converted to perform open heart procedure.Patient later expired.Cause of infusion is unknown.Physician does not feel that it was opsens product related.

• Brand Name: SAVVYWIRE
• Common Device Name: PRE-SHAPED PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750; boulevard parc technologique; quebec, quebec G1P4S 3; CA G1P4S3
• Manufacturer (Section G): OPSENS; 750; boulevard parc technologique; quebec, quebec G1P4S 3; CA G1P4S3
• Manufacturer Contact: maryem oudhini ; 750; boulevard parc technologique; quebec, quebec G1P4S-3 ; CA G1P4S3
• MDR Report Key: 16359022
• Report Number: 3008061490-2023-00001
• Device Sequence Number: 15154360
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)220607(17)240607(10)OSW-0030
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2024
• Device Model Number: F3001
• Device Catalogue Number: SAVVYWIRE XS
• Device Lot Number: OSW-0030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown