MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for RECOVERY CONE REMOVAL SYSTEM RC15 manufactured by Bard Peripheral Vascular, Inc..
[38530057]
No device, 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 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
[38530058]
It was reported that during a vena cava retrieval procedure, the marker band allegedly detached from the recovery cone sheath. Patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
[42958450]
Manufacturing review: a manufacturing review was performed. The lot met all release criteria. Visual/microscopic inspection: the recovery sheath was kinked throughout the entire length; however, after review of preliminary evaluation photos, the manner in which the device was packaged for return caused the kinks. The marker band was detached from the catheter. 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. The distal tip of the sheath was found to be buckled. The polyurethane cone was separated from two of the prongs. Medical records review: as medical records were not provided, a review could not be performed. Image review: based on the images provided, the marker band on the retrieval sheath was intact prior to the successful filter retrieval, became separated after the filter was advanced through the retrieval sheath, the marker band became detached from the retrieval sheath, and surgical forceps successfully captured and retrieved the detached marker band from within the ivc, can be confirmed. Photo review: the photo shows a thin semi circular object that is consistent with the shape of a marker band. Based on the photo provided, a detached marker band cannot be confirmed as the recovery sheath was not included in the photo. Conclusion: based on the returned sample condition and images provided, a detached marker band from the recovery sheath can be confirmed. The sheath tip was found to be buckled and the prongs were separated from the urethane cone; therefore, the investigation is confirmed for buckled material and material separation. Per the reported event details, calcium/fibrotic tissue within the filter likely contributed to the filter being difficult to collapse into the sheath. This likely created tension on the recovery sheath and caused the marker band to detach. In addition the images provided show that the recovery cone captured the filter distal to the filter apex. Per the instructions for use (ifu), "close the cone over the filter tip by advancing the introducer catheter over the cone while holding the pusher shaft stationary. " capturing the filter distal to the filter apex could increase the total diameter of the recovery cone and filter being retrieved which could lead to difficulties retracting into the sheath. The buckled recovery sheath tip and urethane separation from the prongs also were likely the result of the difficulties experienced collapsing the filter into the sheath. Labeling review:the current ifu (instructions for use) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device. (b)(4). Device available for evaluation. 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
[44798383]
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
[44798384]
It was reported that during a vena cava retrieval procedure, the marker band allegedly detached from the recovery cone sheath, but was able to be successfully captured and retrieved with a snare. There was no reported impact or consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-00170 |
| MDR Report Key | 5429490 |
| Date Received | 2016-02-10 |
| Date of Report | 2016-01-15 |
| Date of Event | 2016-01-15 |
| Date Mfgr Received | 2016-04-28 |
| Device Manufacturer Date | 2015-08-24 |
| Date Added to Maude | 2016-02-10 |
| 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 | 2016-02-10 |
| Returned To Mfg | 2016-02-12 |
| Catalog Number | RC15 |
| Lot Number | GFZG3625 |
| 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 WEST 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-10 |