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

Lot Number	0000200069
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a vessel perforation occurred.A wolf venous thrombectomy catheter was selected for use.To begin the procedure, a venogram was performed and ivus was utilized to confirm clot was acute and measure vessel size from ivc down to proximal popliteal-distal sfv (10mm vessel).Through the 14fr wolf sheath, the physician advanced wolf catheter into clot and was able to pull in clot with about 20cm of the sleeve.Upon 3rd 1cm advancement, the physician met a lot of resistance and noted that the catheter would bounce backwards.The physician stopped and then attempted to pull on the sleeve, thinking he was in clot.He did this and also applied forward pressure on the catheter.Once he fully articulated the sleeve, he removed for inspection and did a venogram when a vessel perforation was noted.He rewired, advanced the sheath past the perforation, and opted to go down to a 6mm funneled wolf catheter.He did 2 successful sleeve pulls up to the common fem vein and then did a final sleeve pull back with the 8mm wolf catheter.Next, a wolf thrombectomy sheath was selected for use.Three aspirations were performed with the wolf sheath.It was observed a few times that the vacuum would not release on the wolf sheath.After his final aspiration, they noticed an abnormality in the sheath about 7-10cm away from distal tip.The wolf sheath was removed.An angiojet zelante and two ekos catheters were used to complete the procedure.There were no further patient complications.
Additional Manufacturer Narrative
Device analysis by mfr: the device was returned and analysis completed.A 14f wolf system 8mm x 60cm x 110cm was returned for analysis.Four devortex shafts were returned without the wolf catheter.Visual analysis was performed on the four devortex shafts.No damage or abnormalities were identified to any of the four devortex sleeves or shafts.The 4 devortex all had biomatter within their sleeves.Functional testing could not be performed since the wolf catheter was not returned for analysis, and the 4 devortex were already used.
Event or Problem Description
It was reported that a vessel perforation occurred.A wolf venous thrombectomy catheter was selected for use.To begin the procedure, a venogram was performed and ivus was utilized to confirm clot was acute and measure vessel size from ivc down to proximal popliteal-distal sfv (10mm vessel).Through the 14fr wolf sheath, the physician advanced wolf catheter into clot and was able to pull in clot with about 20cm of the sleeve.Upon 3rd 1cm advancement, the physician met a lot of resistance and noted that the catheter would bounce backwards.The physician stopped and then attempted to pull on the sleeve, thinking he was in clot.He did this and also applied forward pressure on the catheter.Once he fully articulated the sleeve, he removed for inspection and did a venogram when a vessel perforation was noted.He rewired, advanced the sheath past the perforation, and opted to go down to a 6mm funneled wolf catheter.He did 2 successful sleeve pulls up to the common fem vein and then did a final sleeve pull back with the 8mm wolf catheter.Next, a wolf thrombectomy sheath was selected for use.Three aspirations were performed with the wolf sheath.It was observed a few times that the vacuum would not release on the wolf sheath.After his final aspiration, they noticed an abnormality in the sheath about 7-10cm away from distal tip.The wolf sheath was removed.An angiojet zelante and two ekos catheters were used to complete the procedure.There were no further patient complications.It was corrected that an angiojet zelante, two ekos catheters, and a viabahn stent placed over the perforation were used to complete the procedure.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17603461
• Report Number: 2124215-2023-44830
• Device Sequence Number: 17719080
• Product Code: QEW
• UDI-Device Identifier: 00850029546030
• UDI-Public: 00850029546030
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K210911
• 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): 09/15/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2023
• Device Lot Number: 0000200069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Race: Black Or African American