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

Model Number	F3001
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
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 records, lot number osw-0027 was released according to the specification.Dr0575 was associated to the lot, but has no relation to the complaint (replacement of osw ifus for us market).Nc2782 was also associated to the lot, but not related to the complaint as well (supplied packaging hoop had 4 cavities instead of 3).The physician informed opsens that he was having trouble to advance the wire out of the pigtail, a large force was required, so he switched the pigtail and was able to get savvywire out, it was later concluded that this specific model of pigtail catheter used in conjunction with the savvywire tend to require a large force to deliver the wire.Opsens reached out to the physician for additional information, and he stated the following: ''the timing of the injury that caused the pericardial injury is unknown, but i suspect was withdrawal of the pigtail sheath to allow the savvy wire to be positioned in the ventricle.As you know, we later identified the pigtail from a specific manufacturer to be associated with significant resistance moving across the wire so now avoid that pigtail when possible.I did not feel any abnormal "pop" or other tactile sensation that would have concerned me for an injury.'' opsens conducted several tests on the pigtail in questions when used in conjunction with the savvy wire and did not notice any resistance, the required force to get savvywire out is similar to other pigtail catheters in the market, in fact this pigtail has been used in several other procedures in different hospitals and no issue was reported to the attention of opsens.No additional actions are intended following this incident.
Event or Problem Description
Savvywire was used in a difficult case that required multiple exchanges.A pericardial effusion was noticed 1 hour after the case, but the cause of this effusion was not clearly identified during the case.When inserting the savvywire in the left ventricle, physician advice us that a large force was required.It was later identified that this specific model of catheter used in conjunction with the savvywire tend to require a large force to deliver the savvywire.The narrative of the physician is as follow: ''the timing of the injury that caused the pericardial injury is unknown, but i suspect was withdrawal of the pigtail sheath to allow the savvy wire to be positioned in the ventricle.As you know, we later identified the pigtail from a specific manufacturer to be associated with significant resistance moving across the wire so now avoid that pigtail when possible.I did not feel any abnormal "pop" or other tactile sensation that would have concerned me for an injury.'' the pericardial effusion was drained, and the patient fully recovered from this injury.The incident was initially reported among the limited market release forms of the savvy wire us post market registry on the 12th of october 2022, unfortunately the incident was not transferred to the complaint management in time, opsens reached out to the physician on several attempts and was finally able to have the above description of events:.

• 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 du parc technologiqu; quebec, quebec G1P4S 3; CA G1P4S3
• Manufacturer Contact: maryem oudhini ; 750; boulevard du parc technologiqu; quebec, quebec G1P4S-3 ; CA G1P4S3
• MDR Report Key: 16359020
• Report Number: 3008061490-2022-00005
• Device Sequence Number: 6803914
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)220601(17)240601(10)OSW-0027
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/14/2022

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: 06/01/2024
• Device Model Number: F3001
• Device Catalogue Number: SAVVYWIRE XS
• Device Lot Number: OSW-0027
• 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: 12/14/2022
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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: Other
• Patient Sex: Unknown