MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-11 for RECOVERY CONE REMOVAL SYSTEM FBRC manufactured by Bard Peripheral Vascular, Inc..
[35995140]
A further clinical review of the event details was completed and a change in the mdr reportability was identified. No medical records or no medical 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.
Patient Sequence No: 1, Text Type: N, H10
[35995141]
It was reported that during a vena cava filter retrieval procedure, a recovery cone was able to capture the filter; however, the cone became separated and could not retrieve the filter. The recovery cone was removed without incident. Another device was used to successfully capture and retrieve the filter. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[38126395]
Manufacturing review: a manufacturing review was performed. The lot met all release criteria. Visual evaluation: the device was used. The device was received in two segments. The distal portion of the shaft was inside the sheath. The removal cone was protruding slightly from the distal tip of the sheath. The removal device was detached just distal to the shaft handle. The point of detachment was stretched and jagged, likely indicating excessive force used in the attempt to retract the filter into the sheath. The sheath tip was flared as a result of the retrieval attempt. The polyurethane umbrella is partially peeled back from the metal prongs. No other anomalies were noted. Functional/performance evaluation: due to the state of the sample, a functional evaluation could not be performed. Conclusion: based on the returned sample condition, the investigation is confirmed for a detached shaft. The investigation is confirmed for material separation as the polyurethane umbrella was separated from the metal prongs of the recovery cone. Stretching was observed at the point of detachment likely due to excess forced used in the attempt to retract the filter inside the sheath. Therefore, it is possible that user related issues contributed to the detached shaft and partial separation of the polyurethane umbrella. However, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: general information: indications for use: 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: 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 | 2020394-2016-00103 |
| MDR Report Key | 5358302 |
| Date Received | 2016-01-11 |
| Date of Report | 2018-03-21 |
| Date of Event | 2015-03-10 |
| Date Mfgr Received | 2018-02-20 |
| Device Manufacturer Date | 2012-09-05 |
| Date Added to Maude | 2016-01-11 |
| 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 | 2016-01-11 |
| Returned To Mfg | 2015-03-24 |
| Catalog Number | FBRC |
| Lot Number | GFWH0923 |
| Device Expiration Date | 2015-09-30 |
| 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 | 2016-01-11 |