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

Model Number F3001

Device Problem Material Separation (1562)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/23/2023

Event Type  malfunction  

Event Description

Opsens was informed on the (b)(6) that savvywire was introduced into the lv through the 6f pigtail, as the physician was advancing the z-med balloon over the savvywire, it was noticed under the fluro that the wire was broken at the tip.After several attempts the physician was able to snare the wire out of patient's body.Tte revealed that the patient had an effusion and tamponade.Subsequently, blood transfusion was done, and patient status was stabilised.Opsens later reached out to the physician for additional information regarding the case and learned that the patient expired a couple of days after the procedure.

Manufacturer Narrative

Investigation of the wire confirmed the description of the event, a fracture occurred in the wire's tip.The tip also presented a prominent kink 6 mm from the distal end of the wire, the kink occurred while snaring the remain of the tip from the left ventricle.Visual inspection of the wire confirmed that the structural assembly of the wire was done within specification.Check of the device history record confirmed that savvywire lot number osw-0019 was released per specifications.No non-conformity nor deviation were associated with this lot.A possible damage during unpacking, or while advancing the wire could not be determined during this investigation.The following precaution are mentioned in the ifu : 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.Unfortunately, the hospital couldn't provide the case angio images from before the break of wire following opsens's request.Without the angio images, opsens is not able to fully investigate and conclude the exact timing and circumstances of the fracture, therefore no definitive root cause can be assigned for the event.If there is any further relevant information provided, a follow up report will be submitted.

• Brand Name: SAVVYWIRE
• Type of Device: PRE-SHAPED 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 technologique; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 18181924
• MDR Text Key: 328662777
• Report Number: 3008061490-2023-00012
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)240628(17)220628(10)OSW-0019
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K213854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F3001
• Device Lot Number: OSW-0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• 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