MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-10-21 for RECOVERY CONE REMOVAL SYSTEM RC15 manufactured by Bard Peripheral Vascular, Inc..
[28799053]
Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the investigation for a detached marker band is inconclusive. Per the reported event details, the filter had been implanted for approximately 10-11 years. It was also noted that the physician was having difficulties removing the filter as the filter legs allegedly would not collapse into the sheath. It was further reported that the retrieval procedure lasted approximately 90 minutes and upon removal, fibrin was noted to be on some of the limbs. Therefore, it is possible that the difficulties collapsing the filter into the sheath may have contributed to the marker band detachment. The definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: 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 venacavagram (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: 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
[28799054]
It was reported that approximately 11 years post vena cava filter deployment, the patient requested to have the filter removed. The patient was reported to be asymptomatic, prior and post filter retrieval. A recovery cone was used successfully to capture and retrieve the filter; however, difficulty retrieving the filter was experienced. The healthcare provider stated the distal marker band of the retrieval sheath was detached upon visual inspection. An attempt to retrieve the detached distal tip of the deployment sheath was unsuccessful. It is unknown at this time if a snare device or recovery cone were used in the attempt to retrieve the detached tip. At the conclusion of the procedure the detached tip was identified to be located in the right atrium of the heart. At this time it is unknown if another attempt will be made to retrieve the detached tip. The patient was reportedly asymptomatic following the successful filter retrieval procedure.
Patient Sequence No: 1, Text Type: D, B5
[31764434]
(b)(4). New information was received and reviewed. Catalog and lot numbers were provided; therefore, manufacturing review and investigation of the reported event is currently underway.
Patient Sequence No: 1, Text Type: N, H10
[31764435]
New information: upon successful removal of the filter, visual inspection of the retrieval sheath identified a detached marker band. A gooseneck snare was used in an attempt to capture and retrieve the detached marker band. While attempting to remove the detached marker band with the snare device the marker band released from the snare device and migrated to the right atrium. The physician stated it was unknown at the time of the attempted retrieval, the marker band was torn which may have contributed to the marker band releasing from the snare device. Following cardiology consult it was decided that the marker band was too small to be retrieved. The patient was reportedly admitted overnight for observation and completion of anticoagulation bridge. The patient was reported to be asymptomatic.
Patient Sequence No: 1, Text Type: D, B5
[36717055]
Manufacturing review: a manufacturing review was performed. The lot met all release criteria. As the only new information received was catalog and lot number, the investigation conclusion remains unchanged. 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 | 2020394-2015-01740 |
| MDR Report Key | 5163661 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-10-21 |
| Date of Report | 2015-09-23 |
| Date of Event | 2015-09-23 |
| Date Mfgr Received | 2016-01-19 |
| Device Manufacturer Date | 2012-09-05 |
| Date Added to Maude | 2015-10-21 |
| 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 | 2015-10-21 |
| Catalog Number | RC15 |
| Lot Number | GFWH0923 |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2015-10-21 |