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 2017-06-13 for RECOVERY CONE REMOVAL SYSTEM RC15 manufactured by Bard Peripheral Vascular, Inc..
[77516936]
(b)(4). 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 retrieval sheath was returned. The detached marker band was not returned with the retrieval device. The distal end of the retrieval 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 retrieval sheath during manufacturing. A kink was noted in the sheath 33. 9cm from the proximal end of the hub. This kink most likely is due to the configuration in which the sheath was sent back for evaluation. As the user did not complain of the kink this will be an incidental finding. The distal tip of the sheath was also noted to be buckled. No other anomalies were identified on the sheath. Medical records review: no medical records have been made available to the manufacturer. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the device was returned for evaluation. One retrieval sheath was received without a distal marker band. The retrieval sheath clearly showed where the marker band was originally swaged onto the device. The detached marker band was not returned for evaluation. Therefore, the investigation is confirmed for the detached marker band. 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. 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 the ifu (instructions for use). 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
[77516937]
It was reported approximately six months post filter deployment, during a filter retrieval procedure, a vena cava filter removal system was used to successfully capture and remove the filter; however, the radiopaque marker band detached from the sheath and embolized to the pulmonary artery. The marker band was unable to be retrieved. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2017-00616 |
| MDR Report Key | 6639215 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-13 |
| Date of Report | 2017-06-13 |
| Date of Event | 2017-05-18 |
| Date Mfgr Received | 2017-05-18 |
| Device Manufacturer Date | 2017-03-17 |
| Date Added to Maude | 2017-06-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MMX |
| Date Received | 2017-06-13 |
| Returned To Mfg | 2017-06-02 |
| Catalog Number | RC15 |
| Lot Number | GFBN3372 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-06-13 |