MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-14 for RECOVERY CONE REMOVAL SYSTEM RC15 manufactured by Bard Peripheral Vascular, Inc..
[34136769]
As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been received and an investigation of the reported event 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 Sequence No: 1, Text Type: N, H10
[34136770]
It was reported that during a vena cava retrieval procedure, the recovery cone was used off label to retrieve the vena cava filter and the polyurethane cone allegedly became torn. The recovery cone captured the filter and the recovery cone, filter and sheath were removed as a single unit. No additional devices were required. There was no reported impact or consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
[40342852]
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, the subassemblies, the manufacturing process and the 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 complaint reported to date for this failure mode. Visual evaluation: the device was received in two segments. The shaft was inside the sheath with the removal cone protruding out the distal end of the sheath. The handle was returned detached. The sheath tip was flared and the proximal end of the sheath was bunched in appearance as a result of the retrieval attempt. Four of the cone's prongs were separated from the polyurethane. Two of the separated prongs were bent. No other anomalies were noted. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: no images or photos have been made available to the manufacturer. Conclusion: the complaint investigation is confirmed for a detached shaft, material separation, and two bent prongs. It should be noted that per the reported event, the recovery cone was used to retrieve a denali filter. Per the denali ifu (instructions for use), the denali filter should be removed using an intravascular loop snare only. The recovery cone is only indicated for use to percutaneously remove the g2 x filter, g2 express filter, g2 filter and the recovery filter from the vena cava, or facilitate the retrieval of foreign objects from the peripheral vascular system. The recovery cone is not indicated for use to remove a denali filter. Therefore, it is likely that user related issues (use of a recovery cone to remove a denali filter) contributed to the reported event. Labeling review: recovery cone: the current ifu (instructions for use) states: the recovery cone removal system is intended for use to percutaneously remove the g2 x filter, g2 express filter, g2 filter and the recovery filter from the vena cava, or facilitate the retrieval of foreign objects from the peripheral vascular system. Warnings: do not use excessive force when manipulating the cone. Excessive force may damage the catheter or other parts of the recovery cone removal system. Equipment required: 12 french dilator. Directions for use - g2 x filter, g2 express filter, g2 filter or recovery filter removal: insert the guidewire and gently advance it to the location of the g2 x filter, g2 express filter, g2 filter or recovery filter for removal. Pre-dilate the accessed vessel with a 12 french dilator. Advance the 10 french introducer catheter together with its tapered dilator over the guidewire and into the vein, such that the tip of the sheath is approximately 3cm cephalad to the filter tip. Note: the introducer catheter has a radiopaque marker at the distal end of the catheter sheath to assist in visualization. Perform a standard inferior venacavogram (typically 30 ml of contrast medium at 15 ml/s). Check for thrombus within the filter. If there is significant thrombus within the filter, do not remove the g2 x filter, g2 express filter, g2 filter or recovery filter. Capture and removal of the g2 x filter, g2 express filter, g2 filter or the recovery filter: the capture of the g2 x filter, g2 express filter, g2 filter or recovery filter is illustrated in - figure 4 a-e: denali ifu: warning: remove the denali filter using an intravascular loop snare only. 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 Sequence No: 1, Text Type: N, H10
| Report Number | 2020394-2015-02008 |
| MDR Report Key | 5296013 |
| Date Received | 2015-12-14 |
| Date of Report | 2015-11-20 |
| Date of Event | 2015-11-11 |
| Date Mfgr Received | 2016-03-11 |
| Device Manufacturer Date | 2015-08-24 |
| Date Added to Maude | 2015-12-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1625 WEST 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RECOVERY CONE REMOVAL SYSTEM |
| Generic Name | VENA CAVA FILTER REMOVAL SYSTEM |
| Product Code | GAE |
| Date Received | 2015-12-14 |
| Returned To Mfg | 2015-12-02 |
| Catalog Number | RC15 |
| Lot Number | GFZG3625 |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 WEST 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-14 |