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 2016-07-20 for RECOVERY CONE REMOVAL SYSTEM RC15 manufactured by Bard Peripheral Vascular, Inc..
[50075432]
No medical records and no medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The facility rep has stated that the device is available for evaluation. A sample return kit was sent to the facility and is pending return. The results of the device evaluation will be furnished upon completion of the event investigation. 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
[50075433]
It was reported that the marker band allegedly detached from the sheath of the vena cava filter removal system during retraction through the access site. The detached marker band was successfully captured and retrieved with forceps. There was no reported consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
[57601390]
Manufacturing review: a manufacturing review was performed. The lot met all release criteria. Visual evaluation: the recovery cone removal system was returned. The cone was received inserted through the retrieval sheath. The distal marker band was returned detached from the sheath. The detached marker band was not circular in nature and appeared to be in a linear configuration. The retrieval sheath was noted to be torn longitudinally from the distal tip. The tear was noted to be 2. 6cm in length. Skiving was identified at and above the tear for an additional 4. 0cm. The detached marker band configuration and tear in the retrieval sheath were most likely do to the high tension and force associated with attempting to retrieve the denali filter through a sheath that was too small. The distal end of the introducer sheath was examined under microscopic magnification. The distal marker band impression was identified at 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. Functional/performance evaluation: no functional testing was 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 recovery cone removal system was returned for evaluation. The distal marker band was returned separated from the retrieval sheath. Therefore, the investigation was confirmed for a detached marker band. Additionally, evaluation found the retrieval sheath to be torn at the distal end, confirming the investigation for torn material. It should be noted that per evaluation results, 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 alleged marker band detachment and the identified torn retrieval sheath. 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 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
[57601391]
It was reported that the marker band allegedly detached from the sheath of the vena cava filter removal system during retraction through the access site. The detached marker band was successfully captured and retrieved with forceps. There was no reported consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-00667 |
| MDR Report Key | 5811021 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-20 |
| Date of Report | 2016-06-27 |
| Date of Event | 2016-06-24 |
| Date Mfgr Received | 2016-09-22 |
| Device Manufacturer Date | 2015-12-01 |
| Date Added to Maude | 2016-07-20 |
| 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 | 2016-07-20 |
| Returned To Mfg | 2016-08-01 |
| Catalog Number | RC15 |
| Lot Number | GFZI1380 |
| Device Expiration Date | 2015-12-01 |
| 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 | 2016-07-20 |