LIMFLOW ARC
Report
- Report Number
- 3023527320-2025-00001
- Event Type
- Malfunction
- Date Received
- January 22, 2025
- Date of Event
- January 16, 2025
- Report Date
- August 13, 2025
- Manufacturer
- LIMFLOW INC
- Product Code
- PDU
- UDI-DI
- 00850041730158
- PMA / PMN Number
- K221541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR USUAL 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)(6).
THE DEVICE (ARC) IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED BY CONFLUENT MEDICAL TECHNOLOGIES. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THERE HAVE BEEN NO SIMILAR COMPLAINT EVENTS FOR THIS LOT NUMBER. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND EVALUATED. THE CATHETER WAS VISUALLY INSPECTED AND THE ATTENDING LIMFLOW FIELD REPRESENTATIVE WAS INTERVIEWED. BASED ON CONDUCTED MANUFACTURING DOCUMENTATION REVIEW, A LINK TO A MANUFACTURING EVENT DEVIATION COULD NOT BE ESTABLISHED TO EXPLAIN THE ISSUE DESCRIBED IN THIS COMPLAINT REPORT. THE CONTRACT MANUFACTURER HAS CONFIRMED THAT THIS MANUFACTURING LOT HAS BEEN PRODUCED IN ACCORDANCE WITH APPROVED PROCEDURES AND SPECIFICATIONS. EVALUATION OF THE COMPLAINT DEVICE IDENTIFIED A MAJOR TEAR OF THE CATHETER OUTER SHAFT ON THE DISTAL END OF THE DEVICE WHICH ULTIMATELY RESULTED IN THE DETACHMENT OF THE CATHETER TIP DURING DEVICE WITHDRAWAL FROM THE PATIENT. IDENTIFIED DAMAGE ON THE DEVICE'S EXTERNAL SURFACE AND CATHETER TIP DETACHMENT IS INDICATIVE OF THE TRACKING GUIDEWIRE BEING WRAPPED AROUND THE OUTER SHAFT OF THE CATHETER FROM EXCESSIVE ROTATIONS EMPLOYED BY THE USER IN AN ATTEMPT TO PENETRATE THE CALCIFIED ARTERIAL VESSEL WALL. AS NOTED BY THE ATTENDING LIMFLOW FIELD REPRESENTATIVE, WHEN THE USER WAS WITHDRAWING THE COMPLAINT DEVICE OUT FROM THE PATIENT'S BODY, THE CATHETER SHAFT WAS SEEN TO BE WRAPPED BY THE TRACKING GUIDEWIRE. THE RISK OF WIRE WRAP IS ALREADY CAPTURED IN THE LIMFLOW ARC INSTRUCTIONS FOR USE (IFU), WITHIN THE PRECAUTION LIST, AMONG ADDITIONAL OUTLINED POTENTIAL RISKS THAT ARE LISTED BELOW WHICH COULD CONTRIBUTE TO THE OCCURRENCE OF THIS TYPE OF FAILURE. LIMFLOW ARC IFU RELEVANT CAUTIONS: - EXCESSIVE ROTATION, BENDING, OR KINKING OF LIMFLOW ARC MAY AFFECT ITS PERFORMANCE. WITHDRAW THE LIMFLOW ARC IF IT BECOMES EXCESSIVELY KINKED. - EXCESSIVE CALCIFICATION AT THE SITE OF RE-ENTRY MAY IMPAIR PERFORMANCE. - DO NOT ROTATE MORE THAN 360 DEGREES IN ANY ONE DIRECTION AS THIS MAY CAUSE WRAPPING OF THE TRACKING GUIDEWIRE AROUND THE CATHETER SHAFT. BASED ON THE CONDUCTED INVESTIGATION, THE ROOT CAUSE OF THE ISSUE DESCRIBED IN THIS COMPLAINT REPORT HAS BEEN DETERMINED TO BE RELATED TO USE.
A PATIENT WITH CLTI (CHRONIC LIMB-THREATENING ISCHEMIA), CLASSIFIED AS RUTHERFORD CATEGORY 5, UNDERWENT A TADV PROCEDURE (TRANSCATHETER ARTERIALIZATION OF DEEP VEINS) USING THE LIMFLOW DEVICES ON (B)(6) 2025. THE ARC DEVICE WAS FLUSHED WITH VIPERSLIDE AT THE PHYSICIAN'S DISCRETION AND INSERTED INTO THE BODY FOR USE. THE COMMAND GUIDWIRE WAS USED TO DELIVER THE DEVICE. THE PHYSICIAN ORIGINALLY HAD DIFFICULTY THROWING THE NEEDLE FORWARD. THE ACCOUNT MANAGER REMINDED THE PHYSICIAN THAT THE VESSEL WAS EXTREMELY CALCIFIED. AFTER MULTIPLE ATTEMPTS TO SNARE INTO THE V-CEIVER, THE PHYSICIAN NOTICED THE NEEDLE WAS NO LONGER COMMUNICATING TO THE SLIDER. AT THIS MOMENT IT WAS DECIDED TO WALK OUT THE ARC DEVICE. ONCE THE DEVICE WAS OUT OF THE BODY, IT NOTICED THAT THE WIRE WAS WRAPPED MULTIPLE TIMES AROUND THE CATHETER AND THAT THE MONORAIL TIP OF THE CATHETER BROKE OFF. THERE WERE NO REMNANTS OF THE DEVICE LEFT IN THE BODY. THE PHYSICIAN PULLED OUT ANOTHER ARC DEVICE AND CROSSED THE ANATOMY SUCCESSFULLY.
A PATIENT WITH CLTI (CHRONIC LIMB-THREATENING ISCHEMIA), CLASSIFIED AS RUTHERFORD CATEGORY 5, UNDERWENT A TADV PROCEDURE (TRANSCATHETER ARTERIALIZATION OF DEEP VEINS) USING THE LIMFLOW DEVICES ON (B)(6) 2025. THE ARC DEVICE WAS FLUSHED WITH VIPERSLIDE AT THE PHYSICIAN'S DISCRETION AND INSERTED INTO THE BODY FOR USE. THE COMMAND GUIDWIRE WAS USED TO DELIVER THE DEVICE. THE PHYSICIAN ORIGINALLY HAD DIFFICULTY THROWING THE NEEDLE FORWARD. THE ACCOUNT MANAGER REMINDED THE PHYSICIAN THAT THE VESSEL WAS EXTREMELY CALCIFIED. AFTER MULTIPLE ATTEMPTS TO SNARE INTO THE V-CEIVER, THE PHYSICIAN NOTICED THE NEEDLE WAS NO LONGER COMMUNICATING TO THE SLIDER. AT THIS MOMENT IT WAS DECIDED TO WALK OUT THE ARC DEVICE. ONCE THE DEVICE WAS OUT OF THE BODY, IT NOTICED THAT THAT THE WIRE WAS WRAPPED MULTIPLE TIMES AROUND THE CATHETER AND THAT THE MONORAIL TIP OF THE CATHETER BROKE OFF. THERE WERE NO REMNANTS OF THE DEVICE LEFT IN THE BODY. THE PHYSICIAN PULLED OUT ANOTHER ARC DEVICE AND CROSSED THE ANATOMY SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1084659 | LIMFLOW ARC | CATHETER FOR CROSSING TOTAL OCCLUSIONS | PDU | LIMFLOW INC | AC-US-23 | 82310689 | 00850041730158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | COMMAND GUIDEWIRE (ABBOTT)| COMMAND GUIDEWIRE (ABBOTT) |