| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RECOVERY CONE REMOVAL SYSTEM | RECOVERY CONE REMOVAL SYSTEM | BARD PERIPHERAL VASCULAR, INC. | GAE | FBRC | GFYL2281 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-07-29 | 0 |
Patient 1
THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
Patient 1
IT WAS REPORTED THAT DURING A VENA CAVA FILTER RETRIEVAL PROCEDURE USING A RECOVERY CONE THE MARKER BAND SHIFTED PROXIMALLY DURING ADVANCEMENT OF THE SHEATH. THERE WAS NO ATTEMPT TO RETRIEVE THE FILTER, THE SYSTEM WAS REMOVED WITHOUT INCIDENT AND WAS EXCHANGED FOR ANOTHER RECOVERY CONE SYSTEM WHICH WAS PREPPED AND USED TO SUCCESSFULLY RETRIEVE THE FILTER. THERE WAS NOT REPORTED PATIENT INJURY.
Patient 1
THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. VISUAL/MICROSCOPIC INSPECTION: THE MARKER BAND WAS LOCATED APPROXIMATELY 24.9CM FROM THE DISTAL TIP THUS CONFIRMING THE COMPLAINT FOR DISLODGED OR DISLOCATED. THE DISTAL END OF THE INTRODUCER CATHETER WAS EXAMINED UNDER MICROSCOPIC MAGNIFICATION. THE MARKER BAND IMPRESSION WAS IDENTIFIED AT THE APPROPRIATE LOCATION ON THE CATHETER'S SURFACE. THIS INDICATES THAT THE MARKER BAND WAS SWAGED ON THE CATHETER DURING MANUFACTURING. THE DISTAL TIP OF THE INTRODUCER CATHETER WAS SLIGHTLY DAMAGED. IT IS UNKNOWN IF THE DAMAGE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING FOR RETURN. A DAMAGED TIP WAS NOT REPORTED BY THE USER. NO OTHER ANOMALIES WERE IDENTIFIED TO THE CATHETER. FUNCTIONAL/PERFORMANCE EVALUATION: THE MARKER BAND WAS SECURELY ATTACHED AND DID NOT FREELY MOVE ALONG THE LENGTH OF THE INTRODUCER CATHETER. MEDICAL RECORDS REVIEW: NO MEDICAL RECORDS HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. IMAGE/PHOTO REVIEW: NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. CONCLUSION: THE INTRODUCER CATHETER WAS RETURNED. THE INVESTIGATION IS CONFIRMED FOR DISLODGED OR DISLOCATED MARKER BAND. PER THE REPORTED EVENT DETAILS, THE ACCESS SITE WAS PRE-DILATED USING A 9 FRENCH DILATOR. PER THE INSTRUCTIONS FOR USE, THE VESSEL SHOULD BE PRE-DILATED WITH A 12 FRENCH DILATOR. THE PHYSICIAN REPORTED SIGNIFICANT RESISTANCE WHILE ADVANCING THE CATHETER THROUGH THE ACCESS SITE DUE TO THE PATIENT'S BODY HABITUS. THE MARKER BAND LIKELY DISLODGED DUE TO THE RESISTANCE ENCOUNTERED WHILE TRYING TO ADVANCE THE CATHETER THROUGH THE ACCESS SITE. AS THE ACCESS WAS NOT PRE-DILATED TO THE CORRECT SIZE AND THE PHYSICIAN REPORTED RESISTANCE DUE TO THE PATIENT'S BODY HABITUS, THE ROOT CAUSE FOR THE REPORTED EVENT IS LIKELY DUE TO PATIENT AND/OR PROCEDURAL FACTORS. IT SHOULD BE NOTED THAT THE RECOVERY CONE SYSTEM IS NOT INDICATED TO RETRIEVE DENALI FILTERS. PER THE DENALI INSTRUCTIONS FOR USE, REMOVAL OF THE DENALI FILTER SHOULD BE PERFORMED USING AN INTRAVASCULAR LOOP SNARE ONLY. LABELING REVIEW: THE RECOVERY CONE REMOVAL SYSTEM INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE.