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 2015-10-08 for RECOVERY CONE REMOVAL SYSTEM FBRC manufactured by Bard Peripheral Vascular, Inc..
[27837899]
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.
Patient Sequence No: 1, Text Type: N, H10
[27837900]
It was reported that during a vena cava filter retrieval procedure, a recovery cone was used to successfully capture retrieve the filter. However, some resistance was met while capturing the filter inside the retrieval sheath. The use of a recovery cone is an off label use with this filter. Upon removal of the filter, visual inspection identified a detached marker band tip from the retrieval sheath. Guided fluoroscopy demonstrated the detached marker band located in the subcutaneous tissue between the access site and the jugular vein. An attempt was made to retrieve the detached marker band; however, due to the overlying tissue and patient declining the enlargement incision site the marker band remains in the patient with no reported plans for a future removal of the detached tip. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[35691808]
A further clinical review of the event details has been completed and identified a change in the mdr reportability. This event is reportable as a malfunction mdr. Marker band detachment could cause or contribute to a serious injury. There was no reported impact or consequence to the patient. 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
[39551093]
A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event. The lot met all release criteria. Visual/microscopic inspection: 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. Functional/performance evaluation: no anomalies were noted to the recovery cone and pusher delivery system. The distal tip of the introducer sheath was buckled. The distal marker band was not present. 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 not present. The investigation is confirmed for a detached marker band and buckled material. 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 alleged marker band detachment. Note: the sales representative performed an in-servicing with the health care provider on 9/8/2015 on the proper methods and equipment required to successfully retrieve a denali filter. Labeling review: recovery cone: the current ifu (instructions for use) states: general information/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. Denali ifu: warning: remove the denali filter using an intravascular loop snare only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020394-2015-01686 |
| MDR Report Key | 5135473 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-17 |
| Date of Event | 2015-09-16 |
| Date Mfgr Received | 2016-02-23 |
| Device Manufacturer Date | 2014-08-14 |
| Date Added to Maude | 2015-10-08 |
| 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 | 2015-10-08 |
| Returned To Mfg | 2015-10-05 |
| Catalog Number | FBRC |
| Lot Number | GFYG3504 |
| Device Expiration Date | 2017-08-31 |
| 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 | 1. Other | 2015-10-08 |