MAUDE Adverse Event Report: LIMFLOW INC LIMFLOW V-CEIVER; DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	VC-US-23
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient with clti (chronic limb-threatening ischemia), classified as rutherford category 6, underwent a tadv procedure (transcatheter arterialization of deep veins) using the limflow devices on (b)(6) 2024.During the procedure, the v-ceiver was inserted into the patient's lateral plantar vein (lpv) over a command 0.014" guidewire.The guidewire had traversed from the posterior tibial vein through a perforator and to the peroneal vein.Due to the tortuosity of this patient's venous anatomy, the v-ceiver could not traverse through the peroneal vein; the physician attempted to deliver the v-ceiver but was unsuccessful.They decided to retract the v-ceiver and switch out the wire for a stiffer (v14) guidewire however they were still not able to deliver the v-ceiver in the peroneal vein.The physician started to retract the device when the tip became stuck and disconnected from the catheter.The physician made an effort to retrieve the detached tip by ballooning proximal to the top in attempt to drag the tip down into the pedal sheath with no success.Given the inability to retrieve the tip, the decision was made to leave it in place.To prevent migration, a stent was deployed over the tip.
Additional Manufacturer Narrative
The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unsual findings.The device has been returned to the manufacturer for evaluation.Upon completion of the investigation a follow-up report will be submitted.There have been no similar complaint events for this lot number.Manufacturer reference: (b)(4).

• Brand Name: LIMFLOW V-CEIVER
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): LIMFLOW INC; 6001 oak canyon; suite 100; irvine 92618
• Manufacturer (Section G): CONFLUENT MEDICAL TECHNOLOGIES; alajuela province; alajuela, ; CS
• Manufacturer Contact: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 20720077
• Report Number: 3023527320-2024-00002
• Device Sequence Number: 6471507
• Product Code: MMX
• UDI-Device Identifier: 00850041730141
• UDI-Public: 00850041730141
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K222083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2024

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: 02/23/2025
• Device Model Number: VC-US-23
• Device Lot Number: 82300261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4FR SHEATH; COMMAND GUIDEWIRE (ABBOTT); V-14 BOSTON SCIENTIFIC GUIDEWIRE (0.014")
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male