MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-23 for RECOVERY CONE REMOVAL SYSTEM RC15 manufactured by Bard Peripheral Vascular, Inc..
[46200906]
No medical records or no images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The 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
[46200907]
It was reported that during a vena cava filter retrieval procedure, the marker band allegedly detached from the sheath of the vena cava filter removal system. The filter and the detached marker band were successfully captured and retrieved. There was no reported impact or consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
[50765399]
Manufacturing review: 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 cone was received inserted through the retrieval sheath. The distal tip of the sheath was buckled. The distal marker band was returned detached from the sheath. The distal end of the introducer sheath was examined under microscopic magnification. The distal marker band impression was identified on the appropriate location on the sheaths' surface. This indicates that the marker band was swaged on the introducer sheath during manufacturing. No other anomalies were identified on the sheath. 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 recovery cone removal system was returned. The distal tip of the introducer sheath was returned buckled and the marker band was returned detached from the catheter. The investigation is confirmed for a detached marker band and buckled material. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: general information: the recovery cone removal system is intended to percutaneously remove the g2 x filter, g2 express filter, g2 filter, recovery filter or a foreign body as indicated. Indications for use: 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: (b)(4). 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
[50765400]
It was reported that during a vena cava filter retrieval procedure, the marker band allegedly detached from the sheath of the vena cava filter removal system. The filter and the detached marker band were successfully captured and retrieved. There was no reported impact or consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-00460 |
| MDR Report Key | 5673774 |
| Date Received | 2016-05-23 |
| Date of Report | 2016-04-28 |
| Date of Event | 2016-04-28 |
| Date Mfgr Received | 2016-07-27 |
| Device Manufacturer Date | 2015-08-26 |
| Date Added to Maude | 2016-05-23 |
| 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 W 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 | 2016-05-23 |
| Returned To Mfg | 2016-05-09 |
| Catalog Number | RC15 |
| Lot Number | GFZG3634 |
| 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 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-23 |