MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI; VENA CAVA FILTER, TEMPORARY/PERMANENT

Lot Number GFBV2387

Device Problem Component Missing (2306)

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

Event Date 03/15/2018

Event Type  malfunction  

Event Description

Visual examination of an extracted ivc filter demonstrated one missing short strut.

• Brand Name: DENALI
• Type of Device: VENA CAVA FILTER, TEMPORARY/PERMANENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st.; tempe AZ 85281
• MDR Report Key: 7529374
• MDR Text Key: 108755202
• Report Number: 7529374
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2018,05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2020
• Device Lot Number: GFBV2387
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RETRIEVAL DEVICE
• Patient Age: 68 YR