MAUDE Adverse Event Report: DEVORO MEDICAL, INC WOLF THROMBECTOMY SYSTEM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	FD0427-05
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Advance (2920)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an embolism occurred.An 8fr wolf thrombectomy catheter was selected for use.The wolf catheter was placed into the right superficial femoral artery (sfa) through an 8f non-bsc sheath.The device was advanced 1-2cm into the target vessel.The thrombus was engaged, and a sleeve pull was performed which consumed the entire thrombus.Upon removal of the wolf catheter, additional clot was observed in the right profunda.An attempt was made to reload a sleeve on the wolf catheter.During that process, the inner shaft would not exit the attached rotating hemostatic valve (rhv).This resulted in bunching of the sleeve at the distal end.A new wolf catheter was selected, but it was difficult to advance to the sfa.A non-bsc device was then used to remove the remaining clot.There procedure was completed, and there were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the complaint device was returned for product analysis.The device was returned with the wolf inner catheter inside of the wolf outer catheter.One used inner catheter was returned along with the device.Analysis of the touhy showed the orange stopper compressed and extended past the optimal positioning.It was found that the touhy cap had become cracked likely due to over-tightening.This evidence suggests that the user had over-tightened the touhy.During analysis the touhy was loosened and the o-ring remained contracted and prolapsed instead of returning to its opened, relaxed position.A reload was attempted with the cap of the touhy removed, the inner catheter was unable to pass through the touhy.This confirmed the sites complaint of being unable to reload the device.
Event or Problem Description
It was reported that an embolism occurred.An 8fr wolf thrombectomy catheter was selected for use.The wolf catheter was placed into the right superficial femoral artery (sfa) through an 8f non-bsc sheath.The device was advanced 1-2cm into the target vessel.The thrombus was engaged, and a sleeve pull was performed which consumed the entire thrombus.Upon removal of the wolf catheter, additional clot was observed in the right profunda.An attempt was made to reload a sleeve on the wolf catheter.During that process, the inner shaft would not exit the attached rotating hemostatic valve (rhv).This resulted in bunching of the sleeve at the distal end.A new wolf catheter was selected, but it was difficult to advance to the sfa.A non-bsc device was then used to remove the remaining clot.There procedure was completed, and there were no patient complications.

• Brand Name: WOLF THROMBECTOMY SYSTEM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): DEVORO MEDICAL, INC; 46724 lakeview blvd; fremont 94538
• Manufacturer (Section G): DEVORO MEDICAL, INC.; 46724 lakeview blvd; fremont CA 94538
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15846863
• Report Number: 2124215-2022-47906
• Device Sequence Number: 5027269
• Product Code: QEW
• UDI-Device Identifier: 00850029546245
• UDI-Public: 00850029546245
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: FD0427-05
• Device Lot Number: 0000200003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown