MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY CONE REMOVAL SYSTEM; VENA CAVA FILTER REMOVAL SYSTEM

Catalog Number RC15

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that during a vena cava retrieval procedure, the marker band allegedly detached from the recovery cone sheath.Patient status is unknown.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: RECOVERY CONE REMOVAL SYSTEM
• Type of Device: VENA CAVA FILTER REMOVAL SYSTEM
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5429490
• MDR Text Key: 38530057
• Report Number: 2020394-2016-00170
• Device Sequence Number: 1
• Product Code: GAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: RC15
• Device Lot Number: GFZG3625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR