MAUDE Adverse Event Report: COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problems Kinked (1339); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported that during a (b)(6) bird's nest femoral vena cava filter placement procedure, when the filter was advanced through the sheath, the sheath kinked and tore.A second one was opened from a different lot number, it was severely bent and the facility was unable to advance the filter through it.The first two filters had femoral access.The facility opened up a 3rd device and utilized jugular access.They were able to complete the procedure.No unintended section of the device remained inside the patient's body.The product caused or contributed to the need for an additional access site as they switched from femoral to jugular access.No additional adverse effects on the patient were reported due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, specifications, quality control data, trends, and visual inspection was conducted during the investigation.One used gianturco-roehm bird's nest femoral vena cava filter was returned for evaluation.The sheath was torn 21.8 cm from the proximal hub and continued to 24.1 cm from the proximal hub, having a length of 2.3 cm.The dilator was returned inserted into the sheath and was removed from the sheath for examination.A slight compression was noted on the dilator 1.4 cm from the distal end.The dilator was able to be flushed with no difficulty.The sheath was flushed and bio-material exited the distal end.The distal tip of the dilator has a slight compression.The diagnostic catheter was flushed and no nonconformities were identified.The filter cannula was bent 15.5 cm from the proximal hub.The filter cannula was extending from the filter sheath proximal fitting 39.6 cm.The filter catheter was able to be inserted into the sheath and advance with no resistance.The bird's nest filter was deployed from the filter catheter with no difficulties and significant bio-material present.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The ifu cautions users that "overly forceful or multiple jabs with the filter catheter/introducer sheath assembly could result in perforation of the inferior vena cava wall by the exposed hooks and struts of the filter.Do not withdraw the filter catheter/introducer sheath assembly into the iliac vein because repositioning could prove difficult.Do not advance too quickly or forcefully as wire kinking within the filter catheter may occur, making advancement difficult.Based on the provided information provided, inspection of the returned device, and investigation results, a definitive root cause could not be determined.Measures have been conducted to address this failure mode.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6663653
• MDR Text Key: 78297305
• Report Number: 1820334-2017-01485
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002064515
• UDI-Public: (01)00827002064515(17)181111(10)6371166
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: BNF-40-PB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• 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